2005 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
BiDil (isosorbide dinitrate/hydralazine hydrochloride); NitroMed;
For the treatment of heart failure in black patients, Approved June, 2005
Dermatology
Tygacil (tigecycline); Wyeth;
For the treatment of complicated skin and skin structure and intra-abdominal infections and bacterial pneumonia, Approved 2005
Endocrinology
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
Family Medicine
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
Gastroenterology
Tygacil (tigecycline); Wyeth;
For the treatment of complicated skin and skin structure and intra-abdominal infections and bacterial pneumonia, Approved 2005
Hematology
Revlimid (lenalidomide); Celgene;
For the treatment of low- and intermediate-1-risk myelodysplastic syndromes, Approved December 2005
Hepatology (Liver, Pancreatic, Gall Bladder)
Baraclude (entecavir); Bristol-Myers Squibb;
For the treatment of chronic hepatitis B infections with evidence of active viral replication, Approved March, 2005
Nexavar (sorafenib); Bayer/Onyx;
For the Treatment of Renal Cell Carcinoma, Approved December 2005
Immunology
Aptivus (tipranavir); Boehringer Ingelheim;
For the adjunctive treatment of HIV-1 infections, Approved June, 2005
Baraclude (entecavir); Bristol-Myers Squibb;
For the treatment of chronic hepatitis B infections with evidence of active viral replication, Approved March, 2005
Tygacil (tigecycline); Wyeth;
For the treatment of complicated skin and skin structure and intra-abdominal infections and bacterial pneumonia, Approved 2005
Infections and Infectious Diseases
Aptivus (tipranavir); Boehringer Ingelheim;
For the adjunctive treatment of HIV-1 infections, Approved June, 2005
Baraclude (entecavir); Bristol-Myers Squibb;
For the treatment of chronic hepatitis B infections with evidence of active viral replication, Approved March, 2005
Musculoskeletal
Boniva (ibandronate); Roche / GlaxoSmithKline;
For the treatment and prevention of osteoporosis, Approved May, 2003 -- UPDATED: NEW FORMULATION APPROVED MARCH, 2005
Naglazyme (galsulfase); BioMarin Pharmaceuticals;
For the treatment of mucopolysaccharidosis VI (Maroteaux-Lamy syndrome), Approved May 2005
Nephrology
Vaprisol (conivaptan); Astellas Pharma US, Inc;
For the treatment of euvolemic hyponatremia, Approved December 2005
Neurology
Rozerem (ramelteon); Takeda;
For the treatment of sleep-onset insomnia, Approved July, 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
Oncology
Arranon (nelarabine); GlaxoSmithKline;
For the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, Approved October 2005
Nexavar (sorafenib); Bayer/Onyx;
For the Treatment of Renal Cell Carcinoma, Approved December 2005
Pulmonary/Respiratory Diseases
Tygacil (tigecycline); Wyeth;
For the treatment of complicated skin and skin structure and intra-abdominal infections and bacterial pneumonia, Approved 2005
Rheumatology
Orencia (abatacept); Bristol-Myers Squibb;
For the Treatment of Rheumatoid Arthritis, Approved December 2005
The criteria for CenterWatch's FDA-Approved Drugs follow the definitions established by the Tufts Center for the Study of Drug Development and the FDA's definitions of a new drug approval or a new molecular entity.
Database inclusions:
New Molecular Entities (NME) is defined by the FDA as a medication containing an active substance that has never before been approved for marketing in any form in the United States. The database also includes some recombinant proteins and biologics that were approved by the FDA's Center for Drug Evaluation and Research (CDER).
Database exclusions:
Diagnostic agents, generics, over-the-counter products, medical devices, and biologic compounds not approved by CDER. Other exclusions are new dosages and new administrations of previously-approved compounds.
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