2009 FDA Approved Drugs

The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.

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Find out more about the types of drugs included in this listing.

Cardiology/Vascular Diseases

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

Atryn (antithrombin recombinant lyophilized powder for reconstitution); GTC BioTherapeutics; For the prevention of peri-operative and peri-partum thromboembolic events, Approved January 2009

Efient (prasugrel); Eli Lilly; for the prevention of thrombotic cardiovascular complications in acute coronary syndromes, Approved July 2009

Livalo (pitavastatin); Kowa Company; For the treatment of primary hyperlipidemia and mixed dyslipidemia, Approved August 2009

Multaq (dronedarone); Sanofi-aventis; For the treatment of paroxysmal or persistent atrial fibrillation or atrial flutter, Approved July 2009

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

Dermatology

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

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

Endocrinology

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

Family Medicine

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

Gastroenterology

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

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

Zenpep (pancrelipase); Eurand; For the treatment of pancreatic insufficiency due to cystic fibrosis or other conditions, Approved August 2009

Genetic Disease

Berinert (C1 Esterase Inhibitor (Human)); CSL Behring; For the treatment of abdominal or facial attacks of hereditary angioedema, Approved October 2009

Kalbitor (ecallantide); Dyax; For the treatment of hereditary angioedema, 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

Zenpep (pancrelipase); Eurand; For the treatment of pancreatic insufficiency due to cystic fibrosis or other conditions, Approved August 2009

Hematology

Arzerra (ofatumumab); GlaxoSmithKline; For the treatment of chronic lymphocytic leukemia, Approved October 2009

Atryn (antithrombin recombinant lyophilized powder for reconstitution); GTC BioTherapeutics; For the prevention of peri-operative and peri-partum thromboembolic events, Approved January 2009

Efient (prasugrel); Eli Lilly; for the prevention of thrombotic cardiovascular complications in acute coronary syndromes, Approved July 2009

Elitek (rasburicase); sanofi-aventis; For the management of plasma uric acid levels in adults with malignancies, Approved October 2009

Feraheme (ferumoxytol); AMAG; For the treatment of iron deficiency anemia associated with chronic kidney disease, Approved June 2009

Folotyn (pralatrexate injection); Allos Therapeutics; For the treatment of peripheral T-cell lymphoma, Approved September 2009

Istodax (romidepsin); Gloucester Pharmaceuticals; For the treatment of cutaneous T-cell lymphoma, Approved November 2009

Samsca (tolvaptan); Otsuka; For the treatment of hyponatremia, Approved May of 2009

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human); Octapharma; For the treatment of von Willebrand disease, Approved December of 2009

Hepatology (Liver, Pancreatic, Gall Bladder)

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

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

Zenpep (pancrelipase); Eurand; For the treatment of pancreatic insufficiency due to cystic fibrosis or other conditions, Approved August 2009

Immunology

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

Berinert (C1 Esterase Inhibitor (Human)); CSL Behring; For the treatment of abdominal or facial attacks of hereditary angioedema, Approved October 2009

Besivance (besifloxacin ophthalmic suspension); Bausch & Lomb; For the treatment of bacterial conjunctivitis, Approved June 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

Coartem (artemether/lumefantrine); Novartis; For the treatment of malaria infections due to Plasmodium falciparum, Approved April 2009

Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate); GlaxoSmithKline; For the prevention of invasive disease caused by Haemophilus influenzae type b., August of 2009

Ilaris (canakinumab); Novartis; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved June 2009

Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed); Intercell AG; For the prevention of disease caused by Japanese encephalitis virus, Approved March 2009

Kalbitor (ecallantide); Dyax; For the treatment of hereditary angioedema, Approved November 2009

Qutenza (capsaicin); NeurogesX; For the treatment of neuropathic pain associated with postherpetic neuralgia, Approved November 2009

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

Zirgan (ganciclovir ophthalmic gel); Sirion Therapeutics; For the treatment of acute herpetic keratitis, Approved September 2009

Infections and Infectious Diseases

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

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

Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate); GlaxoSmithKline; For the prevention of invasive disease caused by Haemophilus influenzae type b., August of 2009

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

Musculoskeletal

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

Colcrys (colchicine); Mutual Pharmaceuticals; For gout flares and familial Mediterranean fever, Approved October 2009

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

Savella (milnacipran hydrochloride); Forest Laboratories; For the treatment of fibromyalgia, Approved January 2009

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

Nephrology

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

Feraheme (ferumoxytol); AMAG; For the treatment of iron deficiency anemia associated with chronic kidney disease, Approved June 2009

Gelnique (oxybutynin chloride); Watson Pharmaceuticals; For the treatment of overactive bladder, Approved January 2009

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

Neurology

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

Edluar (zolpidem tartrate); Orexo; For the treatment of insomnia, Approved March 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

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

Qutenza (capsaicin); NeurogesX; For the treatment of neuropathic pain associated with postherpetic neuralgia, Approved November 2009

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

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

Obstetrics/Gynecology (Women’s Health)

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

Lysteda (tranexamic acid); Xanodyne Pharmaceuticals; For the treatment of heavy menstrual bleeding, Approved November 2009

Oncology

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

Arzerra (ofatumumab); GlaxoSmithKline; For the treatment of chronic lymphocytic leukemia, Approved October 2009

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

Elitek (rasburicase); sanofi-aventis; For the management of plasma uric acid levels in adults with malignancies, Approved October 2009

Folotyn (pralatrexate injection); Allos Therapeutics; For the treatment of peripheral T-cell lymphoma, Approved September 2009

Istodax (romidepsin); Gloucester Pharmaceuticals; For the treatment of cutaneous T-cell lymphoma, Approved November 2009

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

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

Ophthalmology

Acuvail (ketorolac tromethamine); Allergan; For the treatment of pain and inflammation following cataract surgery., Approved July 2009

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

Besivance (besifloxacin ophthalmic suspension); Bausch & Lomb; For the treatment of bacterial conjunctivitis, Approved June 2009

Ozurdex (dexamethasone); Allergan; For the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion, Approved June 2009

Zirgan (ganciclovir ophthalmic gel); Sirion Therapeutics; For the treatment of acute herpetic keratitis, Approved September 2009

Pediatrics/Neonatology

Berinert (C1 Esterase Inhibitor (Human)); CSL Behring; For the treatment of abdominal or facial attacks of hereditary angioedema, Approved October 2009

Colcrys (colchicine); Mutual Pharmaceuticals; For gout flares and familial Mediterranean fever, Approved October 2009

Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate); GlaxoSmithKline; For the prevention of invasive disease caused by Haemophilus influenzae type b., August of 2009

Ilaris (canakinumab); Novartis; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved June 2009

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

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

Psychiatry/Psychology

Edluar (zolpidem tartrate); Orexo; For the treatment of insomnia, Approved March 2009

Fanapt (iloperidone); Vanda; For the treatment of schizophrenia, Approved May of 2009

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

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

Pulmonary/Respiratory Diseases

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

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

Rheumatology

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

Colcrys (colchicine); Mutual Pharmaceuticals; For gout flares and familial Mediterranean fever, Approved October 2009

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

Uloric (febuxostat); Takeda; For the treatment of chronic hyperuricemia in patients with gout, Approved February 2009

Trauma (Emergency, Injury, Surgery)

Atryn (antithrombin recombinant lyophilized powder for reconstitution); GTC BioTherapeutics; For the prevention of peri-operative and peri-partum thromboembolic events, Approved January 2009

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human); Octapharma; For the treatment of von Willebrand disease, Approved December of 2009

Vaccines

Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate); GlaxoSmithKline; For the prevention of invasive disease caused by Haemophilus influenzae type b., August of 2009