FDA Approved Drugs for Endocrinology

Drugs Approved in 2017

Ozempic (semaglutide); Novo Nordisk; For the treatment of type II diabetes, Approved December 2017

Parsabiv (etelcalcetide); Amgen; For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, Approved February 2017

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

Drugs Approved in 2016

Adlyxin (lixisenatide); Sanofi Aventis; For the treatment of type II diabetes, Approved July 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

Addyi (flibanserin); Sprout Pharmaceuticals; For the treatment of premenopausal women with generalized hypoactive sexual desire disorder, Approved August 2015

Natpara (parathyroid hormone) ; NPS Pharmaceuticals; For the control hypocalcemia in patients with hypoparathyroidism, Approved January 2015

Synjardy (empagliflozin and metformin hydrochloride) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2015

Tresiba (insulin degludec injection); Novo Nordisk; For glycemic control in adults with diabetes mellitus, Approved September 2015

Drugs Approved in 2014

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

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

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

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

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

Signifor LAR (pasireotide); Novartis; For the treatment of acromegaly, Approved December 2014

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

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

Vogelxo (testosterone) gel; Upsher-Smith; For males with a deficiency or absence of endogenous testosterone, Approved June 2014

Xigduo XR (dapagliflozin + metformin hydrochloride); AstraZeneca; For glycemic control in adults with type II diabetes, Approved October 2014

Drugs Approved in 2013

Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of vasomotor symptoms of menopause, Approved July 2013

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

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

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

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

Drugs Approved in 2012

Belviq (lorcaserin hydrochloride); Arena Pharmaceuticals; For the chronic management of weight loss, Approved June 2012

Bio-T-Gel (testosterone gel); Teva Pharmaceutical; For the treatment of hypogonadism, Approved February 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

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

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

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

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

Qsymia (phentermine + topiramate extended-release); Vivus; For the treatment of chronic weight management, Approved July 2012

Signifor (pasireotide diaspartate); Novartis; For the treatment of Cushing's disease, Approved December of 2012

Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012

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

Drugs Approved in 2011

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

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

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

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

Drugs Approved in 2010

Fortesta (testosterone gel); Endo Pharmaceuticals; For the treatment of hypogonadism, Approved December 2010

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

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

Drugs Approved in 2009

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

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

Drugs Approved in 2008

Accretropin (somatropin rDNA Original); Cangene; For the treatment of growth failure in pediatrics, Approved January 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

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

Fenofibrate; LifeCycle Pharma; For the treatment of hyperlipidemia, dyslipidemia and hypertriglyceridemia, Approved August 2007

Somatuline Depot (lanreotide acetate); Beaufour Ipsen; For the treatment of acromegaly, Approved August 2007

Supprelin LA (histrelin acetate); Indevus Pharmaceuticals; For the treatment of central precocious puberty, Approved May 2007

Drugs Approved in 2006

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

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

Drugs Approved in 2005

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

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

Increlex (mecasermin); Tercica; For the treatment of growth failure due to Primary IGFD, Approved August 2005

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

Drugs Approved in 2003

Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003

Fabrazyme (agalsidase beta); Genzyme; For the treatment of Fabry disease in adult patients, Approved April 2003

Somavert (pegvisomant); Pharmacia & Upjohn; Injectable formulation for the treatment of acromegaly, Approved March 2003

Drugs Approved in 2002

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

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

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

Levo-T (levothyroxine sodium); Mova Pharmaceutical; Indicated for the treatment of hypothyroidism and the suppression of thyroid stimulating hormone, Approved March 2002

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

Novothyrox (levothyroxine sodium); Genpharm; For the treatment of hypothyroidism and suppression of thyroid-stimulating hormone, Approved May 2002

Synthroid (levothyroxine sodium); Abbott Laboratories; For replacement or supplemental therapy for hypothyroidism and pituitary thyroid stimulating hormone suppression, Approved July 2002

Testim; Auxilium Pharmaceuticals; External cream for the treatment of male hormone deficiency., Approved October 2002

Drugs Approved in 2001

Campath; Berlex Laboratories; Injectable treatment of B-cell chronic lymphocytic leukemia, Approved May 2001

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

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

Genotropin (somatropin) injection; Pharmacia & Upjohn; For the treatment of growth failure in children who were born small for gestational age (SGA), Approved July 2001

Gleevec (imatinib mesylate); Novartis; Oral therapy for the treatment of chronic myeloid leukemia, Approved May 2001

Levoxyl; Jones Pharma; Oral therapy for the treatment of hypothyroidism and suppression of thyroid-stimulating hormone (TSH), Approved May 2001

Natrecor (nesiritide); Scios; For the treatment of patients with acutely decompensated congestive heart failure, Approved August 2001

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

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

Yasmin (drospirenone/ethinyl estradiol); Berlex Laboratories; Oral contraceptive, Approved May 2001

Zometa (zoledronic acid); Novartis; For the treatment of hypercalcemia of malignancy, Approved August 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

AndroGel testosterone gel; Unimed Pharmaceuticals; For testosterone replacement therapy in males with testosterone deficiency, Approved February 2000

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

Cetrotide; Asta Medica; For the prevention of premature ovulation in women undergoing controlled ovarian stimulation, Approved August 2000

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

Hectorol (Doxercalciferol) Injection; Bone Care International; To reduce iPTH levels in management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis, Approved April 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

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

Mirena (levonorgestrel-releasing intrauterine system); Berlex Laboratories; Hormone-releasing system for intrauterine contraception, Approved December 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

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

Drugs Approved in 1999

ACTOS; Takeda; Treatment for type II diabetes, Approved July 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

Avandia (rosiglitazone maleate); SmithKline Beecham; Treatment for type II diabetes mellitus, Approved June 1999

Cernevit; Baxter Healthcare; For the treatment of vitamin deficiency, Approved April 1999.

Climara; Berlex Laboratories; For the prevention of postmenopausal osteoporosis (loss of bone mass), Approved June 1999

Doxil (doxorubicin HCl liposome injection); Alza; Treatment for ovarian cancer that is refractory to other first-line therapies, Approved June 1999

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

Ethyol (amifostine); US Bioscience, Alza; Treatment for xerostomia (dry mouth) due to radiation, Approved June 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

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

Xenical/Orlistat Capsules; Roche; Treatment for obesity management, Approved April 1999

Drugs Approved in 1998

Actonel; Procter & Gamble, Hoechst Marion Roussel; Treatment for Paget's Disease, Approved April 1998

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

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

CellCept; Roche; Treatment for the prevention of organ rejection inpatients undergoing heart transplants, Approved February 1998

Clomipramine hydrochloride; Mylan Laboratories; Generic equivalent of Anafranil, 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

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

Glucagon; Eli Lilly; Treatment for severe Hypoglycemia, Approved September 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

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

Mircette; Organon; Oral contraceptive, Approved April 1998

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

Prometrium; Schering-Plough; Treatment for Endometrial Hyperplasia, Approved December 1998

Proscar; Merck; Treatment for complication relating to benign prostatic hyperplasia (BPH), Approved April 1998

Simulect; Novartis; Treatment for acute organ transplant rejection, Approved May 1998

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

Zemplar; Abbott Laboratories; Treatment of secondary hyperparathyroidism associated with chronic renal failure, Approved April 1998

Drugs Approved in 1997

Baycol (cerivastatin sodium); Bayer; Treatment for high cholesterol, Approved June 1997; withdrawn 8/8/01

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

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

Crinone 8% (progesterone gel); Wyeth; Treatment for infertile women with pregestone deficiency, Approved May 1997

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

Dostinex Tablets (cabergoline tablets); Pharmacia & Upjohn; Treatment of hyperprolactinemic disorders, Approved January 1997

DynaCirc CR; Novartis; Treatment for hypertension, Approved February 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

Estrostep (norethindrone acetate and ethinyl estradiol); Warner-Lambert; Treatment for oral contraception, Approved March 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

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

Genotropin (somatropin) lyophilized powder; Pharmacia & Upjohn; Treatment for growth hormone deficiency in adults, Approved November 1997

Geref (sermorelin acetate for injection); Serono Laboratories; Treatment for pedicatric growth disorder, Approved October 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

Glyburide Tablets; Roche; Treatment for blood-glucose lowering, Approved December 1997

Glyburide Tablets; Mova Pharmaceutical; Generic version of Glynase PresTab, Approved December 1997

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

MERIDIA; Knoll Pharmaceutical; Treatment for obesity, Approved November 1997

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

Norditropin (somatropin (rDNA origin) for injection); Novo Nordisk; Treatment of children who have growth failure, Approved February 1997

Nutropin (somatropin-rDNA origin); Genentech; Treatment for growth hormone deficiency, Approved December 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

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

Prograf; Fujisawa Healthcare; Treatment for the prevention of kidney transplant rejection, Approved April 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

Skelid (tiludronate disodium); Sanofi-aventis; Treatment for Paget’s disease of bone, Approved March 1997

Testoderm TTS CIII; Alza; Treatment for testosterone deficiency, Approved December 1997

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

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

Trivora-21 and Trivora-28; Watson Pharmaceuticals; Generic equivalents of levonorgestrel and ethinyl estradiol, Approved December 1997

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

Zenapax; Roche; Treatment to prevent rejection of kidney transplants, Approved December 1997

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

Drugs Approved in 1996

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

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

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

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

Covera-HS (verapamil); GD Searle, Alza; Treatment for hypertension and angina, Approved January 1996

Desmopressin Acetate (DDAVP); Rhone Poulenc Rorer; Treatment for central diabetes insipidus, Approved February 1996

Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection); Orphan Medical; Treatment of meningeal leukemia or lymphocytic lymphoma, Approved October 1996

Estrostep (norethindrone acetate and ethinyl estradiol); Parke-Davis; Treatment for birth control, Approved October 1996

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

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

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

Humatrope (somatropin [rDNA origin] for injection); Eli Lilly; Treatment for Somatropin Deficiency Syndrome, Approved August 1996

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

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

Nutropin (somatropin-rDNA origin); Genentech; Treatment that consists of recombinant growth hormone product, Approved January 1996

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

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

Redux (dexfenfluramine hydrochloride); Wyeth; Treatment for obesity, Approved May 1996

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

Saizen; Ares-Serono; Treatment for growth hormone deficiency and Turner Syndrome, Approved May 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

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

Androderm (Testosterone Transdermal System); TheraTech; Treatment for primary and secondary hypogonadism, Approved on September 29, 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

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

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

Leukine (sargramostim); Immunex; Treatment for mobilizing peripheral blood progenitor cells for use after transplantation., Approved on November 24, 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

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