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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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2008

Cardiology/Vascular Diseases

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

Trilipix (fenofibric acid); Abbott Laboratories; For the treatment of dyslipidemia, hypertriglyceridemia and hyperlipidemia, Approved December 2008

Endocrinology

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

Family Medicine

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

Gastroenterology

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

Entereg (alvimopan); GlaxoSmithKline; For the treatment of postoperative ileus, Approved May 2008

Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008

Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting, Approved September 2008

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

Genetic Disease

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

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

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

Hematology

Mozobil (plerixafor injection); Genzyme; For the treatment of non-Hodgkin’s lymphoma and multiple myeloma, Approved December 2008

Nplate (romiplostim); Amgen; For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, Approved August 2008

Promacta (eltrombopag); GlaxoSmithKline; For the treatment of thrombocytopenia, Approved November 2008

Hepatology (Liver, Pancreatic, Gall Bladder)

Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved August 2008

Immunology

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

Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals Inc.; For the treatment of seasonal and perennial allergic rhinitis, Approved October 2008

Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema, Approved October 2008

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

Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics, Approved January 2008

Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008

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

Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved August 2008

Infections and Infectious Diseases

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

Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals Inc.; For the treatment of seasonal and perennial allergic rhinitis, Approved October 2008

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

Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008

Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved August 2008

Musculoskeletal

Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis, Approved April 2008

Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's disease, Approved August 2008

Nephrology

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

Toviaz (fesoterodine fumarate); Pfizer; For the treatment of overactive bladder, Approved October 2008

Neurology

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

Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain associated with ocular surgery, Approved June 2008

Lusedra (fospropofol disodium); Elan Pharmaceuticals; A sedative-hypnotic agent indicated for monitored anesthesia care sedation, Approved December of 2008

Nucynta (tapentadol); Ortho-McNeil Pharmaceutical; moderate to severe acute pain, Approved November 2008

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

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

Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's disease, Approved August 2008

Oncology

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

Fusilev (levoleucovorin); Spectrum Pharmaceuticals; For rescue after high-dose methotrexate therapy in osteosarcoma and to reduce the toxicity of methotrexate, Approved March of 2008

Mozobil (plerixafor injection); Genzyme; For the treatment of non-Hodgkin’s lymphoma and multiple myeloma, Approved December 2008

Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting, Approved September 2008

Treanda (bendamustine hydrochloride); Cephalon; For the treatment of Chronic lymphocytic leukemia and B-cell non-Hodgkin’s lymphoma, Approved October 2008

Ophthalmology

Akten (lidocaine hydrochloride); Akorn; For anesthesia during ophthalmologic procedures, Approved October 2008

Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals Inc.; For the treatment of seasonal and perennial allergic rhinitis, Approved October 2008

Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain associated with ocular surgery, Approved June 2008

Otolaryngology (Ear, Nose, Throat)

Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals Inc.; For the treatment of seasonal and perennial allergic rhinitis, Approved October 2008

Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics, Approved January 2008

Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008

Pediatrics/Neonatology

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

Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema, Approved October 2008

Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics, Approved January 2008

Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis, Approved April 2008

Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008

Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008

Pharmacology/Toxicology

Akten (lidocaine hydrochloride); Akorn; For anesthesia during ophthalmologic procedures, Approved October 2008

Fusilev (levoleucovorin); Spectrum Pharmaceuticals; For rescue after high-dose methotrexate therapy in osteosarcoma and to reduce the toxicity of methotrexate, Approved March of 2008

Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting, Approved September 2008

Psychiatry/Psychology

Aplenzin (bupropion hydrobromide); Biovail Laboratories; For the treatment of major depressive disorder, Approved April 2008

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

Pulmonary/Respiratory Diseases

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

Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008

Rheumatology

Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis, Approved April 2008

Urology

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