FDA Approved Drugs for Family Medicine

Drugs Approved in 2017

Qtern (dapagliflozin and saxagliptin) ; AstraZeneca; For the treatment of inadequately controlled type II diabetes , Approved February 2017

Trulance (plecanatide); Synergy Pharmaceuticals; For the treatment of adults with chronic idiopathic constipation, Approved January 2017

Drugs Approved in 2016

Byvalson (nebivolol and valsartan); Allergan; For the treatment of hypertension, Approved June 2016

Onzetra Xsail (sumatriptan nasal powder) ; Avanir; For the treatment of migraine, Approved January 2016

Soliqua 100/33 (insulin glargine and lixisenatide injection); Sanofi Aventis; For the treatment of inadequately controlled type II diabetes, Approved November 2016

Xultophy 100/3.6 (insulin degludec and liraglutide injection); Novo Nordisk; For the treatment of inadequately controlled type II diabetes, Approved November 2016

Drugs Approved in 2015

Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015

Cresemba (isavuconazonium sulfate) ; Astellas; For the treatment of invasive aspergillosis and invasive mucormycosis, Approved March 2015

Enstilar (calcipotriene and betamethasone dipropionate); LEO Pharmaceuticals; For the treatment of psoriasis, Approved October 2015

Kybella (deoxycholic acid); Kythera Biopharma; For the treatment of submental fat, Approved April 2015

Otiprio (ciprofloxacin otic suspension); Otonomy; For the treatment of pediatrics with bilateral otitis media with effusion undergoing tympanostomy tube placement, Approved December 2015

Savaysa (edoxaban); Daiichi Sankyo; For the treatment of deep vein thrombosis, pulmonary embolism and risk of stroke and embolism due to atrial fibrillation, Approved January 2015

Viberzi (eluxadoline); Actavis; For the treatment of irritable bowel syndrome with diarrhea, Approved May 2015

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of irritable bowel syndrome with diarrhea , Approved May 2015

Drugs Approved in 2014

Afrezza (insulin human) Inhalation Powder; Mannkind; For the treatment of diabetes mellitus, Approved June 2014

Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; Biogen Idec; For the treatment of hemophilia B, Approved March 2014

Arnuity Ellipta (fluticasone furoate inhalation powder); GlaxoSmithKline; For the treatment of asthma, Approved August 2014

Aveed (testosterone undecanoate) injection; Endo Pharmaceuticals; For the treatment of hypogonadism, Approved March 2014

Belsomra (suvorexant); Merck; For the treatment of insomnia, Approved August 2014

Bunavail (buprenorphine and naloxone); BioDelivery Sciences; For the maintenance treatment of opioid dependence, Approved June 2014

Contrave (naltrexone HCl and bupropion HCl) ; Takeda Pharmaceuticals U.S.A.; For chronic weight management , Approved September 2014

Dalvance (dalbavancin); Durata Therapeutics; For the treatment of acute bacterial skin and skin structure infections, Approved May 2014

Dyloject (diclofenac sodium) Injection; Hospira; For the management of mild, moderate or severe pain, Approved December 2014

Entyvio (vedolizumab); Millenium Pharmaceuticals; For the treatment of adults with ulcerative colitis and Crohn's disease, Approved May of 2014

Farxiga (dapagliflozin); Bristol-Myers Squibb; For the treatment of type II diabetes, January of 2014

Grastek (Timothy Grass Pollen Allergen Extract); Merck; For the treatment of grass pollen-induced allergic rhinitis, Approved April 2014

Jardiance (empagliflozin) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2014

Kerydin (tavaborole); Anacor; For the treatment of onychomycosis of the toenails, Approved July 2014

Metronidazole 1.3% Vaginal Gel; Actavis, Inc.; For the treatment of bacterial vaginosis, Approved April 2014

Myalept (metreleptin for injection); Bristol-Myers Squibb; For the treatment of congenital or acquired generalized lipodystrophy, Approved February of 2014

Natesto, (testosterone) nasal gel; Trimel Pharmaceuticals; For the treatment of deficiency or absence of endogenous testosterone, Approved May 2014

Northera (droxidopa); Chelsea Therapeutics; For the treatment of neurogenic orthostatic hypotension, Approved February 2014

Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract); Greer Labs; For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, Approved April 2014

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Otezla (apremilast); Celgene; For the treatment of moderate to severe plaque psoriasis, Approved September 2014

Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis, Approved August 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Ragwitek (Short Ragweed Pollen Allergen Extract); Merck; For the treatment of short ragweed pollen-induced allergic rhinitis, Approved April 2014

Rapivab (peramivir injection); Biocryst; For the treatment of acute uncomplicated influenza in adults, Approved December 2014

Saxenda (liraglutide [rDNA origin] injection); Novo Nordisk; For chronic weight management, Approved December 2014

Tanzeum (albiglutide); GlaxoSmithKline; For the treatment of type II diabetes mellitus, Approved April 2014

Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue Pharma; For the management of severe chronic pain, Approved July 2014

Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014

Trulicity (dulaglutide); Eli Lilly; To improve glycemic control in type II diabetics, Approved September 2014

Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt Pharmaceuticals; For the management of acute pain, Approved March 2014

Xtoro (finafloxacin otic suspension) 0.3%; Alcon; For the treatment of acute otitis externa, Approved December 2014

Zerbaxa (ceftolozane + tazobactam) ; Cubist Pharmaceuticals; For the treatment of complicated intra-abdominal and urinary tract infections, Approved December 2014

Drugs Approved in 2013

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Anoro Ellipta (umeclidinium and vilanterol inhalation powder); GlaxoSmithKline; For the maintenance treatment of chronic obstructive pulmonary disease, Approved December of 2013

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013

Diclegis (doxylamine succinate + pyridoxine hydrochloride DR tablets); Duchesnay USA; For the treatment of nausea and vomiting of pregnancy, Approved April 2013

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 2013

Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013

Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013

Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013

Olysio (simeprevir); Janssen Therapeutics; For the treatment of hepatitis C, November of 2013

Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013

Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013

Sovaldi (sofosbuvir); Gilead Sciences; For the treatment of hepatitis C, December of 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013

Xiaflex (collagenase clostridium histolyticum); Auxilium; For the treatment of Peyronie's disease, Approved December of 2013

Drugs Approved in 2012

Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012

Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012

Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012

Aubagio (teriflunomide); Sanofi Aventis; For the treatment of multiple sclerosis, Approved September 2012

Bydureon (exenatide extended-release for injectable suspension); Amylin; For the improvement of glycemic control in adults with type II diabetes mellitus, Approved January 2012

Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer, Approved November 2012

Cystaran (cysteamine hydrochloride); Sigma Tau Pharmaceuticals; For the treatment of corneal cystine crystal accumulation due to cystinosis, Approved October 2012

Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012

Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012

Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012

Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Jentadueto (linagliptin plus metformin hydrochloride); Eli Lilly; For the treatment of type II diabetes, Approved February 2012

Jetrea (ocriplasmin); Thrombogenics; For the treatment of symptomatic vitreomacular adhesion, Approved October 2012

Korlym (mifepristone); Corcept Therapeutics; For the control of hyperglycemia in adults with endogenous Cushing’s syndrome, Approved February 2012

Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved July 2012

Linzess (linaclotide); Forest Labs and Ironwood Pharmaceuticals; For the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, Approved August 2012

Lucentis (ranibizumab injection); Genentech; For the treatment of diabetic macular edema, Approved August 2012

Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012

Myrbetriq (mirabegron); Astellas Pharma US, Inc; For the treatment of overactive bladder, Approved June 2012

Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer; For the treatment of heavy menstrual bleeding, Approved March 2012

Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012

Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012

Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 2012

Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012

Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012

Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012

Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012

Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012

Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012

Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012

Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012

Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 infection, Approved August 2012

Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012

Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012

Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved July 2012

Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012

Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012

Xeljanz (tofacitinib); Pfizer; For the treatment of moderately to severely active rheumatoid arthritis, Approved November 2012

Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012

Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer, Approved August 2012

Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular pressure, Approved February 2012

Drugs Approved in 2011

Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Anturol (oxybutynin) Gel; Antares Pharma; For the treatment of overactive bladder, Approved December 2011

Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011

Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March 2011

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 in treatment-naive adults, Approved August of 2011

Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011

Edarbi (azilsartan medoxomil); Takeda; For the treatment of hypertension, Approved February 2011

Edarbyclor (azilsartan medoxomil and chlorthalidone); Takeda; For the treatment of hypertension, Approved December of 2011

Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 2011

Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved November 2011

Eylea (aflibercept); Regeneron Pharmaceuticals; For the treatment of neovascular (wet) age-related macular degeneration, Approved November 2011

Ferriprox (deferiprone); Apotex; For the treatment of transfusional iron overload due to thalassemia, Approved October 2011

Firazyr (icatibant); Shire Pharmaceuticals; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

Gralise (gabapentin); Abbott Laboratories; For the treatment of postherpetic neuralgia, Approved February 2011

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of restless legs syndrome, Approved April 2011

Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved November 2011

Juvisync (sitagliptin and simvastatin); Merck; For the treatment of type II diabetes, Approved October 2011

Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011

Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm birth, Approved February 2011

Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011

Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011

Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Potiga (ezogabine); Valeant Pharmaceuticals; For the treatment of partial-onset seizures, Approved June 2011

Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011

Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011

Vandetanib (vandetanib); AstraZeneca; For the treatment of thyroid cancer, Approved April 2011

Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011

Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011

Xarelto (rivaroxaban); Janssen Pharmaceuticals; For the reduction in the risk of stroke and systemic embolism resulting from atrial fibrillation, Approved November 2011

Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011

Drugs Approved in 2010

Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved January 2010

Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple sclerosis, Approved January 2010

Amturnide (aliskiren + amlodipine + hydrochlorothiazide); Novartis; For the treatment of uncontrolled hypertension, Approved December 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved October 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010

Butrans (buprenorphine) Transdermal System; Purdue Pharma; moderate to severe chronic pain, Approved July 2010

Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics with neurologic conditions, Approved July 2010

Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of asthma, Approved June 2010

Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, Approved November 2010

Exalgo (hydromorphone hydrochloride) extended release; Alza; For the management of moderate to severe pain, Approved March 2010

Gilenya (fingolimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved September 2010

Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010

Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010

Jalyn (dutasteride + tamsulosin); GlaxoSmithKline; For the treatment of benign prostatic hyperplasia, Approved June 2010

Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010

Kapvay (clonidine hydrochloride); Shionogi; For the treatment of attention deficit hyperactivity disorder, Approved October 2010

Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia), Approved September 2010

Oleptro (trazodone hydrochloride); Labopharm; For the treatment of major depressive disorder, Approved February 2010

Pradaxa (dabigatran etexilate mesylate); Boehringer Ingelheim; For the risk reduction of stroke and embolism due to atrial fibrillation, Approved October 2010

Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010

Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010

Silenor (doxepin); Somaxon Pharma; For the treatment of insomnia, Approved March 2010

Sprix (ketorolac tromethamine); Roxro Pharma; For the treatment of moderate to severe pain, Approved May 2010

Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010

Tekamlo (aliskiren + amlodipine); Novartis; For the treatment of hypertension, Approved August 2010

Tribenzor (olmesartan medoxomil + amlodipine + hydrochlorothiazide); Daiichi Sankyo; For the treatment of hypertension, Approved July 2010

Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010

Victoza (liraglutide); Novo Nordisk; For the treatment of type 2 diabetes mellitus, Approved January 2010

Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention of relapse to opioid dependence, Approved October 2010

Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis, Approved May 2010

Drugs Approved in 2009

Adcirca (tadalafil); Eli Lilly; For the treatment of pulmonary arterial hypertension, Approved May 2009

Afinitor (everolimus); Novartis; For the treatment of renal cell carcinoma, Approved March 2009

Avastin (bevacizumab); Genentech; For the treatment of renal cell carcinoma, Approved July 2009

Bepreve (bepotastine besilate ophthalmic solution); Ista Pharmaceuticals; For the treatment of itching associated with allergic conjunctivitis, Approved September 2009

Cambia (diclofenac potassium for oral solution); Kowa Pharmaceuticals; For the treatment of migraine attacks, Approved June of 2009

Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant; GlaxoSmithKline; For the prevention of cervical cancer and cervical intraepithelial neoplasia caused by HPV types 16 and 18, Approved October 2009

Cimzia (certolizumab pegol); UCB; For the treatment of rheumatoid arthritis, Approved May of 2009

Cycloset, bromocriptine mesylate; VeroScience; For the treatment of type 2 diabetes mellitus, Approved May 2009

Embeda (morphine sulfate and naltrexone hydrochloride); King Pharmaceuticals; For the treatment of moderate to severe pain, Approved August of 2009

Extavia (Interferon beta-l b); Novartis; For the treatment of relapsing multiple sclerosis, Approved August of 2009

Intuniv (guanfacine extended-release); Shire Pharmaceuticals; For the treatment of ADHD in children and adolescents, Approved September 2009

Metozolv ODT (metoclopramide hydrochloride); Salix Pharmaceuticals; For the treatment of gastroesophageal reflux and diabetic gastroparesis, Approved September of 2009

Onglyza (saxagliptin); Bristol-Myers Squibb; For the treatment of type 2 diabetes mellitus, Approved July 2009

Onsolis (fentanyl buccal); BioDelivery Sciences; For the management of breakthrough cancer pain, Approved July 2009

Pennsaid (diclofenac sodium topical solution); Nuvo Research; For the treatment of osteoarthritis of the knee, Approved November 2009

Sabril (vigabatrin); Lundbeck; For the treatment of infantile spasms and complex partial seizures, Approved August 2009

Saphris (asenapine); Schering-Plough; For the treatment of schizophrenia and manic or mixed bipolar 1 episodes, Approved August of 2009

Simponi (golimumab); Centocor Ortho Biotech; For the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, Approved April 2009

Stelara (ustekinumab); Janssen Biotech; For the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease, Approved September 2009

Tyvaso (treprostinil); United Therapeutics; For the treatment of pulmonary arterial hypertension, Approved July 2009

Vibativ (telavancin); Theravance; For the treatment of complicated skin and skin structure infections, Approved September 2009

Votrient (pazopanib); GlaxoSmithKline; For the treatment of renal cell carcinoma, Approved October of 2009

Zipsor (diclofenac potassium); Xanodyne Pharmaceuticals; For the treatment of mild to moderate acute pain, Approved June 2009

Drugs Approved in 2008

Alvesco (ciclesonide); Nycomed; For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents, Approved January 2008

Aptivus (tipranavir); Boehringer Ingelheim; For the treatment of HIV, Approved June 2008

Banzel (rufinamide); Elan Pharmaceuticals; For the treatment of seizures associated with Lennox-Gastaut syndrome in pediatrics and adults, Approved November 2008

Cimzia (certolizumab pegol); UCB; For the treatment of Crohn’s disease, Approved April 2008

Cleviprex (clevidipine); The Medicines Company; For the treatment of hypertension when oral therapy is not feasible or not desirable, Approved August 2008

Degarelix (degarelix for injection); Ferring Pharmaceuticals; For the treatment of prostate cancer, Approved December of 2008

Intelence (etravirine); Tibotec; For the treatment of HIV-1, Approved January 2008

Stavzor (valproic acid delayed release); Banner Pharmacaps; For the treatment of bipolar manic disorder, seizures and migraine headaches, Approved July 2008

Tysabri (natalizumab); Biogen IDEC; For the maintenance treatment of moderate to severe Crohn’s disease, Approved January 2008

Vimpat (lacosamide); Schwarz Pharma; For the treatment of partial-onset seizures in adults with epilepsy, Approved October 2008

Welchol (colesevelam hydrochloride); Daiichi Sankyo; For the improvement of glycemic control in adults with type 2 diabetes mellitus, Approved January 2008

Drugs Approved in 2007

Amrix (cyclobenzaprine hydrochloride extended release); Cephalon; For the treatment of muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007

Azor (amlodipine besylate; olmesartan medoxomil); Daiichi Sankyo; For the treatment of hypertension, Approved September 2007

Doribax (doripenem); Johnson & Johnson; For the treatment of intra-abdominal infections and urinary tract infections, Approved October 2007

Evamist (estradiol); Vivus; For the treatment of moderate to severe vasomotor symptoms due to menopause, Approved July 2007

Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007

Exelon (rivastigmine tartrate); Novartis; For the treatment of Alzheimer's and Parkinson's disease-related dementia, Approved July 2007

Hycamtin (topotecan hydrochloride); GlaxoSmithKline; For the treatment of small cell lung cancer, Approved October 2007

Isentress (raltegravir); Merck; For the treatment of HIV-1, Approved October 2007

Ixempra (ixabepilone); Bristol-Myers Squibb; For the treatment of breast cancer, Approved October 2007

Letairis (ambrisentan); Gilead; For the treatment of pulmonary arterial hypertension, Approved June 2007

Neupro (rotigotine); Schwarz Pharma; For the treatment of Parkinson's disease, Approved May 2007

Reclast (zoledronic acid); Novartis; For the treatment of postmenopausal osteoporosis, Approved August 2007

Renvela (sevelamer carbonate); Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved October 2007

Selzentry (maraviroc); Pfizer; For the treatment of CCR5-tropic HIV-1, Approved August 2007

Soliris (eculizumab); Alexion; For the treatment of paroxysmal nocturnal hemoglobinuria, Approved March 2007

Tekturna (aliskiren); Novartis; For the treatment of hypertension, Approved March 2007

Torisel (temsirolimus); Wyeth; For the treatment of renal cell carcinoma, Approved May 2007

Tykerb (lapatinib); GlaxoSmithKline; For the treatment of breast cancer, Approved March 2007

Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of Attention-Deficit/Hyperactivity Disorder, Approved February 2007

Drugs Approved in 2006

Desonate (desonide); Dow Pharm; For the treatment of atopic dermatitis, Approved October 2006

Elestrin (estradiol gel); BioSante; For the treatment of vasomotor symptoms associated with menopause, Approved December 2006

Eraxis (anidulafungin); Pfizer; For the treatment of Candida fungal infections, Approved February 2006

Januvia (sitagliptin phosphate); Merck; For the treatment of type II diabetes, Approved October 2006

Noxafil (posaconazole); Schering-Plough; For the treatment of fungal infections, Approved in September 2006

Prezista (darunavir); Tibotec; For the treatment of treatment-resistant HIV infections, Approved June 2006

Ranexa (ranolazine); CV Therapeutics; For the treatment of chronic angina in patients failing first-line therapy, Approved January 2006

Vectibix (panitumumab); Amgen; For the treatment of colorectal cancer, Approved September 2006

Verdeso (desonide); Connetics Corporation; For the treatment of atopic dermatitis, Approved September 2006

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the treatment of alcohol dependence, Approved April 2006

Drugs Approved in 2005

ACTOplus met (pioglitazone hydrochloride and metformin hydrochloride); Takeda; For the treatment of type 2 diabetes, Approved August of 2005

Aptivus (tipranavir); Boehringer Ingelheim; For the adjunctive treatment of HIV-1 infections, Approved June, 2005

BiDil (isosorbide dinitrate/hydralazine hydrochloride); NitroMed; For the treatment of heart failure in black patients, Approved June, 2005

Boniva (ibandronate); Roche / GlaxoSmithKline; For the treatment and prevention of osteoporosis, Approved May, 2003 -- UPDATED: NEW FORMULATION APPROVED MARCH, 2005

Byetta (exenatide); Amylin/Eli Lilly; For the adjunctive treatment of Type 2 diabetes mellitus, Approved April, 2005

Nexavar (sorafenib); Bayer/Onyx; For the Treatment of Renal Cell Carcinoma, Approved December 2005

Orencia (abatacept); Bristol-Myers Squibb; For the Treatment of Rheumatoid Arthritis, Approved December 2005

Symlin (pramlintide); Amylin Pharmaceuticals; For the treatment of type I and type II diabetes, Approved March 2005

Tysabri (natalizumab); Elan Pharmaceuticals / Biogen Idec; For the treatment of relapsing forms of multiple sclerosis, Approved November 2004 -- Updated: Suspended February 2005--Updated: sBLA

Drugs Approved in 2004

Apokyn (apomorphine hydrochloride); Mylan Laboratories; For the treatment of acute, intermittent hypomobility episodes associated with advanced Parkinson’s disease, Approved April, 2004

Avastin (bevacizumab); Genentech; For the treatment of metastatic carcinoma of the colon or rectum, Approved February 2004

Caduet (amlodipine/atorvastatin); Pfizer; For the treatment of hypertension, chronic stable angina and vasospastic angina, Approved January 2004

Campral (acamprosate calcium); Forest Laboratories; For the treatment of alcohol dependence and the maintenance of alcohol abstinence, Approved August, 2004

Cymbalta (duloxetine); Eli Lilly; For the treatment of major depressive disorder, Approved August 2004

Erbitux (cetuximab); Imclone, Bristol-Myers Squibb; For the treatment of EGFR-expressing, metastatic colorectal cancer, Approved February 2004

EstroGel (estradiol gel 0.06%); Solvay Pharmaceuticals; For the treatment of vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, Approved April 2004

Lyrica (pregabalin); Pfizer; For the treatment of pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, Approved December 2004

Spiriva HandiHaler (tiotropium bromide); Boehringer Ingelheim; For the treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved February 2004

Tarceva (erlotinib, OSI 774); Genentech, OSI Pharmaceuticals; For the treatment of advanced refractory metastatic non-small cell lung cancer, Approved November, 2004

Vioxx (rofecoxib); Merck; For the treatment of rheumatoid arthritis, Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004

Drugs Approved in 2003

Amevive (alefacept); Biogen IDEC; For moderate to severe chronic plaque psoriasis., Approved January 2003

Cialis (tadalafil); Eli Lilly; Oral agent for the treatment for erectile dysfunction, Approved December 2003

Finacea (azelaic acid) Gel, 15%; Berlex Laboratories; Gel formulation for the treatment of rosacea., January 2003

Fuzeon (enfuvirtide); Trimeris, Roche; For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved March 2003

Iressa (gefitinib); AstraZeneca; For the second-line treatment of non-small-cell lung cancer, Approved May 2003

Levitra (vardenafil); Bayer, GlaxoSmithKline; For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003

Lexiva (fosamprenavir calcium); GlaxoSmithKline; For the treatment of HIV infection in adults in combination with other antiretroviral agents., Approved October 2003

Namenda (memantine HCl); Forest Laboratories; For the treatment of moderate to severe dementia of the Alzheimer’s type., Approved October 2003

Plenaxis (abarelix for injectable suspension); Praecis Pharmaceuticals; For treatment of advanced prostate cancer, Approved December 2003

Premarin (conjugated estrogens); Wyeth; For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003

Reyataz (atazanavir sulfate); Bristol-Myers Squibb; For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved July 2003

UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis; For the treatment of of the signs and symptoms of benign prostatic hyperplasia, Approved June 2003

Xolair (omalizumab); Genentech; For the treatment of asthma, Approved June 2003

Drugs Approved in 2002

Aciphex (rabeprazole sodium); Elan Pharmaceuticals; For the treatment of symptomatic gastroesophageal reflux disease, Approved February 2002

Alora; Watson Pharmaceuticals; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms, Approved April 2002

Avandamet (rosiglitazone maleate and metformin HCl); GlaxoSmithKline; For improvement of glycemic control in type 2 diabetes patients, Approved October 2002

Avinza (morphine sulfate); Elan Pharmaceuticals; Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy, Approved March 2002

Benicar; Daiichi Sankyo; Oral tablet for the treatment of hypertension, Approved April 2002

Botox Cosmetic (botulinum toxin type A); Allergan; For the temporary improvement in the appearance of glabellar lines (brow furrow), Approved April 2002

Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals; Human-derived follicle-stimulating hormone (hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002

Eligard (leuprolide acetate); Atrix Laboratories; For the palliative treatment of advanced prostate cancer, Approved January 2002

Enbrel (etanercept); Immunex; For the treatment of psoriatic arthritis, Approved January 2002

Faslodex (fulvestrant); AstraZeneca; For the treatment of hormone receptor positive metastatic breast cancer, Approved April 2002

Forteo (teriparatide); Eli Lilly; For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002

Humira (adalimumab); Abbott Laboratories; For the treatment of moderately to severely active rheumatoid arthritis, Approved December 2002

Inspra (eplerenone tablets); Pharmacia & Upjohn; Oral tablets for the treatment of high blood pressure., Approved September 2002

Lexapro (escitalopram oxalate); Forest Laboratories; An orally administered selective serotonin reuptake inhibitor useful for the treatment for major depressive disorder, Approved August 2002

Metaglip (glipizide/metformin HCl); Bristol-Myers Squibb; Oral tablets for the treatment of type 2 diabetes., Approved October 2002

Paxil CR (paroxetine hydrochloride); GlaxoSmithKline; Oral tablet for the treatment of depression and panic disorder, Approved February 2002

Qvar (beclomethasone dipropionate); Ivax; For the treatment of asthma, Approved May 2002

Rebif (interferon beta-1a); Serono Laboratories; Subcutaneous injection for the treatment of relapsing forms of multiple sclerosis, Approved March 2002

Relpax (eletriptan hydrobromide); Pfizer; For the acute treatment of migraine headaches, Approved December 2002

Remicade (infliximab); Centocor Ortho Biotech; Intravenous infusion for the treatment of rheumatoid arthritis, Approved February 2002

Remodulin (treprostinil); United Therapeutics; For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms, Approved May 2002

Ritalin LA (methylphenidate HCl); Novartis; Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD), Approved June 2002

Strattera (atomoxetine HCl); Eli Lilly; For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002

Sustiva; Bristol-Myers Squibb; Once-daily oral tablet for the the treatment of HIV infection, Approved February 2002

Vfend (voriconazole); Pfizer; For the treatment of fungal infections, Approved May 2002

Zelnorm (tegaserod maleate) Tablets; Novartis; For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation, Approved July 2002

Drugs Approved in 2001

Adderall XR; Shire Pharmaceuticals; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD), Approved October 2001

Advicor (extended-release niacin/lovastatin); Kos Pharmaceuticals; For the treatment of cholesterol disorders, Approved December 2001

Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of bacterial infections, Approved November 2001

Axert (almotriptan malate) tablets; Pharmacia & Upjohn; For the treatment of migraine attacks, Approved May 2001

Bayer Extra Strength Asprin; Bayer; Oral treatment for mild to moderate migraine pain, Approved October 2001

Bextra; Pharmacia, Pfizer; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved November 2001

Cancidas; Merck; Intravenous infusion for the treatment of invasive aspergillosis, Approved January 2001

Diovan (valsartan); Novartis; Oral capsules and tablets for the treatment of hypertension, Approved January 1997 (capsules); July 2001 (tablets)

DuoNeb (albuterol sulfate and ipratropium bromide); Dey Laboratories; For the treatment of bronchospasm associated with COPD, Approved March 2001

Dutasteride; GlaxoSmithKline; For the treatment of symptomatic benign prostatic hyperplasia, Approved November 2001

Elidel; Novartis; Topical cream for the treatment of atopic dermatitis, Approved December 2001

Entocort EC (budesonide); AstraZeneca; Capsules for the treatment of mild-to-moderate, active Crohn's disease, Approved October 2001

Estrostep (norethindrone acetate and ethinyl estradiol); Pfizer; For the treatment of moderate acne vulgaris, Approved July 2001

Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001

Finevin; Berlex Laboratories; Topical cream for the treatment of mild to moderate inflammatory acne vulgaris, Approved May 2001

Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001

Foradil Aerolizer (formoterol fumarate inhalation powder); Novartis; Bronchodilator for COPD, asthma and bronchospasm, Approved February 2001 (asthma, bronchospasm); September 2001 (COPD)

Frova (frovatriptan succinate); Elan Pharmaceuticals; Tablets for the acute treatment of migraine attacks, Approved November 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

Kineret; Amgen; Injectable therapy for the treatment of rheumatoid arthritis, Approved November 2001

Lamisil Solution, 1%; Novartis; Topical treatment for tinea (pityriasis) versicolor, althete's foot, jock itch, and ringworm, Approved March 2001

Lumigan (bimatoprost ophthalmic solution); Allergan; For the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Approved March 2001

Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001

Nexium (esomeprazole magnesium); AstraZeneca; For the eradication of Helicobacter pylori, the healing of erosive esophagitis, and the treatment of symptomatic GERD, Approved February 2001

Novolog Mix 70/30; Novo Nordisk; Subcutaneous injection for the control of hyperglycemia, associated with type 1 and 2 diabetes, Approved November 2001

Protonix (pantoprazole sodium) Intravenous Formulation; Wyeth; For the short-term treatment of gastroesophageal reflux disease, Approved March 2001

Prozac Weekly (fluoxetine HCl); Eli Lilly; For the treatment of depression, Approved February 2001

Remeron SolTab (mirtazapine); Organon; Orally disintegrating tablet for the treatment of depression, Approved January 2001

Remicade (infliximab); Centocor Ortho Biotech; For inhibiting the progression of structural damage in patients with rheumatoid arthritis, Approved January 2001

Reminyl (galantamine hydrobromide); Janssen Pharmaceuticals; For the treatment of mild to moderate dementia of the Alzheimer's type, Approved February 2001

Spectracef; TAP Pharmaceuticals; Oral tablets for the treatment of mild to moderate bacterial infections, Approved August 2001

Supartz; Smith & Nephew Orthopaedics; Joint fluid therapy for treatment of osteoarthritis in the knee, Approved January 2001

Tavist (clemastine fumarate); Novartis; Oral tablet for temporary relief of symptoms associated with hay fever, allergic rhinitis, and the common cold, Approved March 2001

Teveten (eprosartan mesylate plus hydrochlorothiazide); Unimed Pharmaceuticals; Tablets for the treatment of hypertension, Approved November 2001

Tracleer (bosentan); Actelion; For the treatment of pulmonary arterial hypertension, Approved November 2001

Travatan (travoprost ophthalmic solution); Alcon; For the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Approved March 2001

Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001

Tricor (fenofibrate); Abbott Laboratories; For the treatment of primary hypercholesterolemia, mixed lipidemia and hypertriglyceridemia, Approved September 2001

Ultracet (acetaminophen and tramadol HCl); Ortho-McNeil Pharmaceutical; For the short-term management of acute pain, Approved August 2001

Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March 2001

Ventolin HFA (albuterol sulfate inhalation aerosol); GlaxoSmithKline; For the treatment or prevention of bronchospasm, Approved April 2001

Viread (tenofovir disoproxil fumarate); Gilead; Once-daily oral tablet for the treatment of human immunodeficiency virus (HIV) infection, Approved October 2001

Zomig (zolmitriptan); AstraZeneca; Orally disintegrating tablet for the treatment of acute migraine in adults, Approved February 2001

Drugs Approved in 2000

Activella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause, Approved April 2000

Atacand (candesartan cilexetil); AstraZeneca; For the treatment of hypertension, Approved September 2000

Benzamycin (erythromycin 3%-benzoyl peroxide 5% topical gel); Dermik Laboratories; For the topical treatment of acne vulgaris, Approved November 2000

Betaxon; Alcon; For lowering IOP in patients with chronic open-angle glaucoma or ocular hypertension, Approved February 2000

Biaxin XL (clarithromycin extended-release tablets); Abbott Laboratories; For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis, Approved March 2000

Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000

Children's Motrin Cold; McNeil Consumer Products; For temporary relief of the common cold, Approved August 2000

Clindamycin phosphate topical gel; Target Research Associates; For once a day treatment of acne vulgaris, Approved November 2000

Colazal (balsalazide disodium); Salix Pharmaceuticals; Mild to moderately active ulcerative colitis, Approved July 2000

Concerta; Alza; For the treatment of Attention Deficit Hyperactivity Disorder, Approved August 2000

Depakote ER (divalproex sodium); Abbott Laboratories; For the prophylaxis (prevention) of migraine headaches in adults, Approved August 2000

Diltiazem HCL, Extended-Release Capsules; Biovail Laboratories; For the reduction of high blood pressure, Approved January 2000

Exelon (rivastigmine tartrate); Novartis; Indicated for the treatment of mild to moderate dementia of the Alzheimer's type, Approved April 2000

Kaletra Capsules and Oral Solution; Abbott Laboratories; For the treatment of HIV-1 infection, Approved September 2000

Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot, jock itch and ringworm, Approved March 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia, Approved April 2000

Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For the treatment of type I and type II diabetes mellitus in adults and pediatrics, Approved April 2000

Lescol XL (fluvastatin sodium) tablet, extended release; Novartis; For the use as an adjunct to diet to reduce elevated total cholesterol, Approved October 2000

Lotrisone (clotrimazole/betamethasone diproprionate) lotion; Schering-Plough; For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis, Approved December 2000

Lotronex (alosetron HCL) Tablets; GlaxoSmithKline; Indicated for Irritable Bowel Syndrome (IBS) in females with diarrhea-predominant IBS, Approved February 2000

Micardis HCT (telmisartan and hydrochlorothiazide); Boehringer Ingelheim; For the treatment of hypertension, Approved November 2000

Mobic (meloxicam) Tablets; Boehringer Ingelheim; For relief of the signs and symptoms of osteoarthritis, Approved April 2000

Neurontin (gabapentin) oral solution; Parke-Davis; Treatment of partial seizures in adults with epilepsy, Approved March 2000

Neurontin (gabapentin) oral solution; Parke-Davis; For the treatment of partial seizures in pediatric patients three years of age and older, Approved October 2000

Nitrostat (nitroglycerin) Tablets; Parke-Davis; For the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease., Approved May 2000

Novantrone (mitoxantrone hydrochloride); Immunex; For reducing neurologic disability and/or the frequency of clinical relapses in patients with multiple sclerosis, Approved October 2000

NovoLog (insulin aspart); Novo Nordisk; An insulin analogue for the treatment of diabetes mellitus., Approved June 2000

Ovidrel (gonadotropin, chorionic human recombinant); Serono Laboratories; For the induction of final follicular maturation and early luteinization in infertile women, Approved September 2000

Pepcid Complete; Merck; For use in the relief of heartburn associated with acid indigestion and sour stomach, Approved October 2000

Protonix (pantoprazole sodium) Delayed-Release Tablets; Wyeth; For treatment of erosive esophagitis, Approved February 2000

Protopic (tacrolimus) ointment; Fujisawa Healthcare; For short-term and intermittent long-term treatment of moderate to severe atopic dermatitis, Approved December 2000

Renagel (sevelamer hydrochloride); Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000

Rescula (unoprostone isopropyl ophthalmic solution) 0.15%; Ciba Vision; For the treatment of open-angle glaucoma or ocular hypertension, Approved August 2000

Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research Associates; For the palliative treatment of advanced prostate cancer, Approved June 2000

Trileptal (oxcarbazepine) Tablets; Novartis; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults), Approved January 2000

Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet; GlaxoSmithKline; For the treatment of HIV-1 infection, Approved November 2000

Venofer (iron sucrose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000

Viadur (leuprolide acetate implant); Alza; For pain relief in men with advanced prostate cancer, Approved March 2000

Vivelle (estradiol transdermal system); Novartis; For the prevention of postmenopausal osteoporosis, Approved August 2000

Zonegran (zonisamide) Capsules; Dainippon Pharmaceutical; Adjunctive therapy for treatment of partial seizures in adults with epilepsy, Approved March 2000

Drugs Approved in 1999

Accolate; AstraZeneca; zafirlukast, 10 mg and 20 mg tablets., Approved September 1999

Aggrenox; Boehringer Ingelheim; Aggrenox (aspirin/extended-release dipyridamole) 25mg/200mg capules for the prevention of recurrence of stroke, Approved November 1999

Aromasin Tablets; Pharmacia & Upjohn; Exemestane Tablets, 25 mg, October 21, 1999

Comtan; Novartis; 200mg entacapone tablets, October 19, 1999

Ellence; Pharmacia & Upjohn; epirubicin hydrochloride, Approved September 1999

Evista (raloxifene hydrochloride); Eli Lilly; Osteoporosis treatment, Approved September 1999

Femhrt Tablets; Parke-Davis; Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg), October 15, 1999

Keppra; UCB; Levetiracetam tablets for adjunctive treatment of partial onset seizures in adults with epilepsy, Approved November 1999

Ortho-Prefest; Ortho-McNeil Pharmaceutical, RW Johnson; 17 beta estradiol/17 beta estradiol norgestimate tablets, October 22, 1999

Synercid I.V.; Rhone Poulenc Rorer; quinupristin and dalfopristin for injection, Approved September 1999

Drugs Approved in 1998

Amerge; GlaxoSmithKline; Treatment for acute migraine, Approved February 1998

Arava; Hoechst Marion Roussel; Treatment for Rheumatoid Arthritis, Approved September 1998

Celexa; Forest Laboratories; Treatment for depression, Approved July 1998

Cimetidine Hydrochloride Oral Solution; Pharmaceutical Formulations; Generic equivalent of Tagamet HB 200, Approved June 1998

Clomipramine hydrochloride; Mylan Laboratories; Generic equivalent of Anafranil, Approved April 1998

Clonazepam; Watson Pharmaceuticals; Generic equivalent of Klonopin, Approved January 1998

Cosopt; Merck; Treatment for glaucoma or ocular hypertension, Approved April 1998

Diovan HCT (valsartan); Novartis; Treatment for hypertension, Approved March 1998

Esclim; Fournier Research; Treatment for symptoms associated to Menopause, Approved August 1998

Estratab (.3 mg ); Solvay Pharmaceuticals; Treatment for the prevention of osteoporosis, Approved March 1998

Etodolac; Faulding; Generic equivalent of Lodine 500 mg tablets, Approved May 1998

Excedrin Migraine; Bristol-Myers Squibb; Treatment for mild to moderate migraine pain, Approved January 1998

Gemzar (gemcitabine HCL); Eli Lilly; Treatment for Lung Cancer, Approved August 1998

Glucagon; Eli Lilly; Treatment for severe hypoglycemia associated with diabetes., Approved October 1998

Glyburide Tablets; Mylan Laboratories; Treatment for Diabetes Mellitus (Type II), Approved July 1998.

Herceptin; Genentech; Treatment for metastatic breast cancer, Approved October 1998

Inform HER-2/neu breast cancer test; Oncor; Treatment for breast cancer prediction, Approved January 1998

Lamictal Chewable Dispersible Tablets; GlaxoSmithKline; Treatment for Epilepsy, Approved August 1998

Lodine XL (etodolac); Wyeth; Treatment for arthritis, Approved February 1998

Lovenox (enoxaparin sodium) Injection; Rhone Poulenc Rorer; Treatment for prevention of blood clots following hip-replacement surgery, Approved February 1998

Marplan Tablets; Roche; Treatment of Depression, Approved August 1998

Maxalt; Merck; Acute treatment of migraine headache, Approved June 1998

Naltrexone Hydrochloride Tablets; Barr Laboratories; Generic equivalent of Revia, Approved May 1998

Noritate; Dermik Laboratories; Treatment for rosacea, Approved January 1998

Photofrin; QLT; Treatment for early-stage, microinvasive endobronchial non-small cell lung cancer, Approved January 1998

Prempro; Wyeth; Treatment for hormone replacement therapy, Approved January 1998

PREVACID(R) (lansopraxole); TAP Pharmaceuticals; Treatment of heartburn associated with GERD, Approved April 1998

Prilosec (omeprazole); Astra Merck; Treatment for heartburn, Approved January 1998

Proleukin; Chiron; Treatment for metastatic melanoma, Approved January 1998

Prometrium; Solvay Pharmaceuticals; Treatment for amenorrhea (abnormal cessation of menses), Approved May 1998

Rocephin; Roche; Treatment for pediatric otitis media, Approved January 1998

Singulair; Merck; Treatment for asthma, Approved February 1998

Sulfamylon; Mylan Laboratories; Treatment used to control bacterial infections on excised burn wounds, Approved June 1998

Synagis; MedImmune; Treatment for the prevention of serious lower respiratory tract disease in infants, Approved June 1998

Tasmar; Roche; Treatment for Parkinson's Disease, Approved January 1998

Tiazac (diltiazem hydrochloride); Forest Laboratories; Treatment for chronic stable angina, Approved February 1998

Viagra; Pfizer; Treatment for impotence, Approved March 1998

Vitravene Injection; Isis Pharmaceuticals; Treatment for CMV in AIDS patients, Approved August 1998

Xeloda; Roche; Treatment for advanced breast cancer tumors, Approved April 1998

Zantac 75 Efferdose; GlaxoSmithKline; Treatment for heartburn, Approved March 1998

Drugs Approved in 1997

INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed); SmithKline Beecham; Treatment for diphtheria, tetanus and pertussis (whooping cough) in infants and children, January 1997

Aphthasol; Block Drug Company; Treatment for canker sores, Approved December 1997

Arthrotec; Searle; Treatment for arthritis, Approved December 1997

Asacol (mesalamine); Procter & Gamble; Treatment of ulcerative colitis, Approved August 1997

Avita Gel; Penederm; Treatment for acne, Approved January 1997

Bactroban Cream; SmithKline Beecham; Treatment for secondarily infected traumatic skin lesions, Approved December 1997

Bromfenac; Duract, Wyeth-Ayerst Laboratories; Management of acute pain, Approved July 1997

Captopril and hydrochlorotiazide; Mylan Laboratories; Treatment for hypertension, Approved May 1997

Carbatrol; Elan Pharmaceuticals; Treatment for epileptic seizures and trigeminal neuralgia, Approved September 1997

Ceftin (cefuroxime axetil); GlaxoSmithKline; Treatment of secondary bacterial infections of acute bronchitis, Approved September 1997

Cimetadine Hydrochloride Oral Solution 300mg/5ml; Morton Grove Pharmaceuticals; Generic equivalent of Tagamet Oral Solution, Approved October 1997

Cimetidine Hydrochloride Oral Solution; Hi-Tech Pharmacal; Generic equivalent of Tagamet Oral Solution, 300 mg/5 ml, Approved October 1997

Cipro (ciprofloxacin HCl); Bayer; Treatment for acute sinusitis, Approved June 1997

Clindamycin Phosphate Topical Solution USP 1%; Morton Grove Pharmaceuticals; Generic equivalent of CLEOCIN Topical Solution 1%, Approved July 1997

Combivir; GlaxoSmithKline; Treatment for AIDS and HIV Infection, Approved September 1997

Copaxone; Teva Pharmaceutical; Treatment for relapsing-remitting multiple sclerosis, Approved January 1997

Corlopam; Neurex; Treatment for severe high blood pressure, Approved September 1997

Dermagraft-TC; Advanced Tissue Sciences; Treatment for partial-thickness and severe burns, Approved October 1997

Diovan (valsartan); Ciba Pharmaceuticals; Treatment for hypertension, Approved January 1997

DynaCirc CR; Novartis; Treatment for hypertension, Approved February 1997

EDEX; Schwarz Pharma; Treatment for erectile dysfunction, Approved June 1997

Effexor XR (venlafaxin HCI); Wyeth; Treatment of depression, Approved October 1997

Estradiol tablets; Barr Laboratories; Generic equivalent of Estrace, Approved October 1997

Estradiol tablets; Duramed Pharmaceuticals; Generic equivalent of Estrace tablets, Approved December 1997

Etodolac; Royce Laboratories; Generic equivalent of Lodine, Approved December 1997

Etodolac; Royce Laboratories; Generic equivalent of Lodine, Approved April 1997

Evista (raloxifene hydrochloride); Eli Lilly; Treatment for the prevention of osteoporosis, Approved December 1997

Femara (letrozole); Novartis; Treatment for breast cancer, Approved July 1997

FEMSTAT One; Roche; Treatment for vaginal yeast infections, Approved Februrary 1997

FLOMAX; Boehringer Ingelheim; Treatment for benign prostatic hypertrophy (BPH), Approved October 1997

Flovent Rotadisk; GlaxoSmithKline; Treatment of asthma in patients four and older, Approved November 1997

Floxin otic; Daiichi Sankyo; Treatment for otitis media, Approved December 1997

Follistim (TM) (follitropin beta for injection); Organon; Treatment for infertility, Approved September 1997

Fortovase; Roche; Treatment for HIV infection, Approved November 1997

Gliadel Wafer (polifeprosan 20 with carmustine implant); Rhone-Poulenc Rorer, Guilford Pharmaceuticals; Treatment for brain cancer, Approved February 1997

Glipizide Tablets; Duramed Pharmaceuticals; Treatment for diabetes, Approved September 1997

Gonal-F (follitropin alfa for injection); Serono Laboratories; Treatment for infertility, Approved September 1997

Imitrex (sumatriptan) injection and tablets; GlaxoSmithKline; Treatment for migraine headaches, Approved August 1997

Imitrex (sumatriptan) nasal spray; GlaxoSmithKline; Treatment for migraine, Approved November 1997

Interstim Continence Control Therapy; Medtronic; Treatment for incontinence, Approved September 1997

Klaron (sodium sulfacet amide lotion ) Lotion, 10%; Dermik Laboratories; Treatment for adult acne, Approved February 1997

Lescol (fluvastatin sodium); Novartis; Treatment for coronary atherosclerosis, Approved September 1997

Lexxel (enalapril maleate-felodipine ER); Astra Merck; Treatment for hypertension, Approved January 1997

Lupron Depot (leuprolide acetate for depot suspension); TAP Pharmaceuticals; Treatment for prostate cancer, Approved July 1997

LUVOX (fluvoxamine maleate); Solvay Pharmaceuticals, Pharmacia & Upjohn; Treatment for obsessive compulsive disorder (OCD) in children and adolescents, Approved April 1997

Mentax (1% butenafine HCl cream); Penederm; Treatment for athlete's foot, Approved December 1997

Metaprotereol Sulfate Inhalation Solution, 5%; Morton Grove Pharmaceuticals; Generic equivalent of Alupentr Inhalation Solution, 5%, Approved March 1997

Microzide (hydrochlorothiazide); Watson Pharmaceuticals; Treatment for mild-to moderate hypertension, Approved January 1997

Migranal; Novartis; Treatment for migraine headaches, Approved December 1997

Minoxidil Topical Solution 2% for Women; Alpharma; Generic equivalent of Rogaine, Approved April 1997

Mirapex; Pharmacia & Upjohn, Boehringer Ingelheim; Treatment for Parkinson’s Disease, Approved June 1997

NORCO tablets (Hydrocodone Bitartrate/Acetaminophen 10 mg/325 mg); Watson Pharmaceuticals; Treatment for moderate to moderately severe pain, Approved February 1997

Norvir (ritonavir); Abbott Laboratories; Treatment for HIV infection, Approved March 1996/March 1997

Omnicef; Warner-Lambert; Treatment against various bacterias, Approved December 1997

Ortho Tri-Cyclen Tablets (norgestimate/ethinyl estradiol); Ortho-McNeil Pharmaceutical; Treatment for acne in women seeking contraception, Approved January 1997

Pindolol; Teva Pharmaceutical; Generic equivalent of Visken, Approved April 1997

Plavix (clopidogrel bisulfate); Sanofi-aventis, Bristol-Myers Squibb; Treatment for cardiac atherosclerotic events, Approved November 1997

Posicor; Roche; Treatment for hypertension and chronic stable angina pectoris, Approved June 1997

Pramipexole; Pharmacia & Upjohn; Treatment for Parkinson's Disease, Approved July 1997

Prandin; Novo Nordisk; Treatment for Type II diabetes, Approved December 1997

Prevpac; TAP Pharmaceuticals; Treatment for duodenal ulcers, Approved December 1997

Propecia; Merck; Treatment for male baldness, Approved December 1997

Quadramet (Samarium Sm 153 Lexidronam Injection); DuPont Merck Pharmaceutical Company; Treatment for pain associated with bone cancer, Approved March 1997

Ranitidine Capsules; Geneva Pharmaceuticals; Generic equivalent of Zantac GELdose, Approved October 1997

Ranitidine Tablets; Apotex; Generic equivalent of Zantac, Approved September 1997

Raxar (grepafloxacin); GlaxoSmithKline; Treatment for chronic bronchitis, Approved November 1997

REGRANEX (becaplermin) Gel; RW Johnson; Treatment for diabetic foot ulcers, Approved December 1997

REPRONEX(menotropins for injection, USP); Ferring Pharmaceuticals; Generic equivalent of Pergonal, Approved February 1997

Requip (ropinirole hydrochloride); SmithKline Beecham; Treatment for Parkinson's Disease, Approved September 1997

Rescriptor Tablets (delavirdine mesylate tablets); Pharmacia & Upjohn; Treatment for HIV-1 infection, Approved April 1997

Retin-A Micro (tretinoin gel) microsphere, 0.1%; Advanced Polymer Systems; Treatment for acne, Approved February 1997

Selegiline tablets; Teva Pharmaceutical; Generic equivalent of Eldepryl tablets, Approved January 1997

Serevent; GlaxoSmithKline; Treatment of asthma, Approved September 1997

SPORANOX (itraconazole); Janssen Pharmaceuticals; Treatment for oral thrush, Approved March 1997

Synvisc, Synvisc-One (Hylan GF 20); Genzyme; For the treatment of pain associated with osteoarthritis of the knee, Approved August 1997

Tazorac topical gel; Allergan; Treatment for Psoriasis, Acne Vulgaris, Approved June 1997

Teveten (eprosartan mesylate); SmithKline Beecham; Treatment for hypertension, Approved December 1997

Tilade (nedocromil sodium); Rhone Poulenc Rorer; Treatment for mild to moderate asthma, Approved November 1997

Tilade (nedocromil sodium); Rhone Poulenc Rorer; Treatment for asthma, Approved April 1997

Tilade (nedocromil sodium); Rhone Poulenc Rorer; Treatment for mild-to-moderate bronchial asthma, Approved April 1997

Tolmetin Sodium; Teva Pharmaceutical; Treatment for arthritis, Approved March 1997

Topamax (topiramate); Ortho-McNeil Pharmaceutical; Treatment for partial onset seizures, Approved January 1997

Trazadone 150mg; Teva Pharmaceutical; Generic equivalent of Desyrel 7, Approved May 1997

Trovan; Pfizer; Treatment for bacterial infections, Approved December 1997

Vanceril 84 mcg Double Strength (beclomethasone dipropionate, 84 mcg) Inhalation Aerosol; Schering-Plough; Treatment for asthma, Approved January 1997

Verapamil; IVAX; Generic equivalent of Knoll's Isoptin SR and Searle's Calan SR, Approved December 1997

VIRACEPT (nelfinavir mesylate); Agouron Pharmaceuticals; Treatment for HIV infection in adults and children, Approved March 1997

Zagam (sparfloxacin) tablets; Rhone Poulenc Rorer; Treatment for community-acquired pneumonia (CAP) and chronic bronchitis, Approved January 1997

Zerit (stavudine); Bristol-Myers Squibb; Treatment for infants and children infected with HIV, Approved January 1997

Zoloft (sertraline HCl); Pfizer; Treatment for panic disorder, Approved July 1997

Zoloft (sertraline HCl); Pfizer; Treatment of panic disorder in children ages 6-17, Approved October 1997

Zomig (zolmitriptan); AstraZeneca; Treatment for migraine, Approved November 1997

Zyflo (Zileuton); Abbott Laboratories; Treatment for asthma in patients 12 years and older, Approved January 1997

Drugs Approved in 1996

Accolate; AstraZeneca; Treatment for asthma, Approved October 1996

Adderall (mixed salts of a single-entity amphetamine); Richwood Pharmaceutical; Treatment for attention-deficit/hyperactivity disorder, Supplemental NDA Approved February 1996

Alphagan (brimonidine); Allergan; Treatment for open-angle glaucoma and ocular hypertension, Approved September 1996

Anexsia; Mallinckrodt Group; Treatment for chronic pain, Approved August 1996

Apthasol (Amlexanox); Access Pharmaceuticals; Treatment for canker sores, Approved May 1996

Aredia (pamidronate disodium for injection); Chiron; Treatment for osteolytic bone metastases of breast cancer, Approved August 1996

ARICEPT (donepezil hydrochloride); Eisai; Treatment for Alzheimer's Disease, Approved December 1996

Arimidex (anastrozole); AstraZeneca; Treatment for advanced breast cancer in postmenopausal women, Approved January 1996

Atrovent (ipratropium bromide); Boehringer Ingelheim; Treatment for runny nose due to allergies and the common cold, Approved January 1996

Augmentin (amoxicillin/clavulanate); SmithKline Beecham; Treatment for infections involving drug-resistant bacteria, Approved February 1996

Axid AR (nizatidine; Whitehall-Robins Healthcare; Over-the-counter anti-ulcer treatment, Approved May 1996

Azmacort (triamcinolone acetonide) Inhalation Aerosol; Rhone Poulenc Rorer; Treatment for asthma, Approved November 1996

Azulfidine EN-tabs Tablets (sulfasalazine delayed release tablets, USP); Pharmacia & Upjohn; Treatment for rheumatoid arthritis, Approved October 1996

Campostar; Pharmacia & Upjohn; Treatment for metastatic colorectal cancer, Approved June 1996

Carrington patch; Carrington Laboratories; Treatment for canker sores, Approved May 1996

CEA-Scan; Immunomedics; Diagnostic imaging product for colorectal cancer, Approved April 1996

Children's Advil (pediatric ibuprofen); Whitehall-Robins Healthcare; Treatment of fever and minor aches and pains, Approved July 1996

Claritin Syrup (loratadine); Schering-Plough; Treatment for children with seasonal allergies, Approved October 1996

Confide; Johnson & Johnson; HIV testing and counseling service, Approved May 1996

Crixivan (Indinavir sulfate); Merck; Treatment for HIV infection, Approved March 1996

DentiPatch (lidocaine transoral delivery system); Noven Pharmaceuticals; Dental anesthetic patch, Approved May 1996

Depakote (divalproex sodium); Abbott Laboratories; Treatment for epilepsy, Approved June 1996

Depakote (divalproex sodium); Abbott Laboratories; Treatment for migraine headaches, Approved March 1996

Differin (adapalene gel) Gel, 0.1%; Galderma Laboratories; Treatment for acne, Approved June 1996

Elmiron (pentosan polysulfate sodium); IVAX; Treatment for interstitial cystitis, Approved October 1996

Eulexin (flutamide); Schering-Plough; Treatment for prostate cancer, Approved June 1996

FemPatch; Parke-Davis; Treatment for menopausal symptoms, Approved December 1996

Feridex I.V.; Advanced Magnetics; Contrast agent for magnetic resonance imaging of liver lesions, Approved February 1996

Fertinex (urofollitropin for injection, purified); Serono Laboratories; Treatment for patients undergoing infertility treatments, Approved September 1996

Gastrocrom Oral Concentrate (cromolyn sodium); Rhone Poulenc Rorer; Treatment for mastocytosis, Approved April 1996

GastroMARK; Advanced Magnetics; Contrast agent for magnetic resonance imaging of the gastrointestinal tract, Approved May 1996

Gemzar (gemcitabine HCL); Eli Lilly; Treatment for pancreatic cancer, Approved May 1996

Glyset (miglitol); Bayer; Treatment for Type II (non-insulin-dependent) diabetes mellitus, Approved December 1996

Humalog (insulin lispro); Eli Lilly; Treatment for type I and type II diabetes, Approved June 1996

Hycamtin (topotecan hydrochloride); SmithKline Beecham; Treatment for metastatic ovarian cancer, Approved May 1996

Kadian; Purepac Pharmaceutical; Treatment for chronic moderate to severe pain, Approved July 1996

Lamisil (terbinafine hydrochloride) Tablets; Sandoz Pharmaceuticals; Treatment for nail fungal infections, Approved May 1996

Leukine (sargramostim); Immunex; Treatment for the replenishment of white blood cells, Approved November 1996

Lithobid (Lithium Carbonate); Solvay Pharmaceuticals; Treatment for manic depression, Approved January 1996

Lodine (etodolac); Wyeth; Treatment for rheumatoid arthritis, Approved July 1996

Lupron Depot (leuprolide acetate for depot suspension); Abbott Laboratories; Treatment for advanced prostate cancer, Approved January 1996

Mavik (trandolapril); Knoll Pharmaceutical; Treatment for hypertension, Approved May 1996

Monistat 3 (miconazole nitrate); Johnson & Johnson; Over the counter treatment for vaginal yeast infections, Approved April 1996

Monurol; Forest Laboratories; Treatment for uncomplicated urinary tract infection, Approved December 1996

Muse; Vivus; Treatment for impotence, Approved October 1996

Naprelan (naproxen sodium); Elan Pharmaceuticals, Wyeth; Treatment for osteoarthritis and rheumatoid arthritis, Approved January 1996

Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals; Treatment for vitamin B-12 deficiency, Approved November 1996

Ocuflox (ofloxacin opthalmic solution) 0.3%; Allergan; Treatment for corneal ulcers, Approved May 1996

OcuHist; Pfizer; Over-the-counter antihistamine eye drop, Approved January 1996

Oral Cytovene; Roche; Treatment for the prevention of cytomegalovirus (CMV), Approved December 1996

OxyContin (oxycodone HCl controlled-release); Purdue Pharma; Treatment for pain associated with musculoskeletal conditions, Approved May 1996

Paxil (paroxetine hydrochloride); SmithKline Beecham; Treatment for panic disorder, Approved May 1996

Photodynamic Therapy; Sanofi-aventis; Photodynamic therapy device for the treatment of esophageal cancer, Approved January, 1996

Pravachol (pravastatin sodium); Bristol-Myers Squibb; Treatment for heart disease, Approved April 1996

Pravachol (pravastatin sodium); Bristol-Myers Squibb; Treatment for cholesterol-lowering, Approved July 1996

Prilosec (omeprazole); Astra Merck; Treatment for heartburn, gastroesophageal reflux disease (GERD), Approved December 1996

Prilosec (omeprazole); Astra Merck; Treatment for gastric ulcers, Approved March 1996

Prilosec (omeprazole)/Biaxin (clarithromycin) Combination Therapy; Astra Merck, Abbott Laboratories; Treatment for duodenal ulcers, Approved April 1996

ProAmatine (midodrine); Roberts Pharmaceutical; Treatment for hypotension, Approved September 1996

Procanbid (procainamide hydrochloride extended-release tablets); Warner-Lambert; Treatment for ventricular arrhythmias, Approved January 1996

Remeron (Mirtazapine); Organon; Treatment for depression, Approved June 1996

RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); MedImmune; Treatment for the prevention of respiratory syncytial virus disease, Approved January 1996

Retavase (reteplase); Boehringer Mannheim Corporation; Treatment for patients suffering from heart attack, Approved November 1996

Tavist (clemastine fumarate); Sandoz Pharmaceuticals; Treatment for cold symptoms, Approved November 1996

Taxotere (Docetaxel); Rhone Poulenc Rorer; Treatment for locally advanced or metastatic breast cancer, Approved May 1996

Teczem (enalapril maleate/diltiazem malate); Hoechst Marion Roussel; Treatment for hypertension, Approved October 1996

Tegretol (carbamazepine); Ciba Pharmaceuticals; Treatment for young children with epilepsy, Approved March 1996

Tegretol XR (carbamazepine); Ciba-Geigy; Anti-epileptic treatment, Approved May 1996

Tiazac (diltiazem hydrochloride); Forest Laboratories; Treatment for hypertension, Approved February 1996

UltraJect; Mallinckrodt Group; Treatment for chronic pain, Approved August 1996

Videx (didanosine); Bristol-Myers Squibb; Treatment of HIV infection, Approved June 1996

Viramune (nevirapine); Boehringer Ingelheim; Treatment for HIV infection, Approved June 1996

Vistide (cidofovir); Gilead; Treatment for cytomegalovirus (CMV) retinitis, Approved June 1996

Vitrasert Implant; Chiron; Drug delivery system for the treatment of cytomegalovirus, Approved March 1996

Vivelle (estradiol transdermal system); Ciba Pharmaceuticals; Treatment for moderate and severe vasomotor menopausal symptoms, Approved March 1996

Zoladex (10.8 mg goserelin acetate implant); AstraZeneca; Treatment for advanced prostate cancer, Approved January 1996

Drugs Approved in 1995

Amaryl (Glimepiride); Hoechst Marion Roussel; Treatment for type II diabetes, Approved December 1995

Avonex (Interferon Beta 1-A); Biogen IDEC; Treatment for multiple sclerosis, Recommended for Approval in December 1995

Caverject (alprostadil); Upjohn; Treatment for impotence, Approved on July 6, 1995

Cedax (ceftibuten); Schering-Plough; Treatment for chronic bronchitis, acute bacterial otitis media, pharyngitis/tonsillitis, Approved December 1995

Clarithromycin (Biaxin); Abbott Laboratories; Treatment for the prevention of disseminated Mycobacterium avium complex (MAC), Approved December 1995

Epivir (lamivudine); GlaxoSmithKline; Treatment used in combination with AZT for AIDS/HIV infection, Approved on November 17, 1995

Ethyol (amifostine); Alza; Treatment to reduce renal toxicity associated with chemotherapy in subjects with advanced ovarian cancer, Approved December 8, 1995

Femstat 3 (butoconazole nitrate 2%); Procter & Gamble, Roche; Over the counter treatment for vaginal yeast infections, Approved December 1995

Fosamax (alendronate sodium); Merck; Treatment for osteoporosis in women after menopause and Paget's Disease of Bone, Approved on September 29, 1995

Intron A (Interferon alfa-2b, recombinant); Schering-Plough; An adjuvant treatment to surgery in subjects at high risk for systemic recurrence of malignant melanoma, Approved December 1995

Invirase (saquinavir); Roche; Treatment for HIV/AIDS, Approved on December 7, 1995

Miacalcin (calcitonin-salmon) Nasal Spray; Sandoz Pharmaceuticals; Treatment for post-menopausal osteoporosis, Approved on August 17, 1995

Precose (acarbose); Bayer; Treatment for non-insulin-dependent diabetes mellitus, Approved September 6, 1995

Prempro & Premphase (conjugated estrogens/medroxyprogesterone acetate tablets); Wyeth; Treatment for postmenopausal hormone replacement, postmenopausal osteoporosis, Approved November 1995

Prinivil or Zestril (Lisinopril); Merck, Zeneca; Treatment for hypertension, heart failure, and acute myocardial infarction, Approved November 24, 1995

Self-examination breast pad; Inventive Products; Self-examination breast pad, Approved on December 22, 1995

Toprol-XL (metoprolol succinate); AstraZeneca; For the treatment of hypertension, angina pectoris and heart failure, Approved January 1995

Western blot confirmatory device; Epitope; Confirmatory test for HIV, Approved in December 1995

Zerit (stavudine); Bristol-Myers Squibb; Treatment for HIV-infected adults who are intolerant of approved therapies, Approved December 22, 1995