2004 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
Caduet (amlodipine/atorvastatin); Pfizer;
For the treatment of hypertension, chronic stable angina and vasospastic angina, Approved January 2004
Family Medicine
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For the treatment of rheumatoid arthritis, Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004
Gastroenterology
Avastin (bevacizumab); Genentech;
For the treatment of metastatic carcinoma of the colon or rectum, Approved February 2004
Erbitux (cetuximab); Imclone, Bristol-Myers Squibb;
For the treatment of EGFR-expressing, metastatic colorectal cancer, Approved February 2004
Hematology
Vidaza (azacitidine); Pharmion Corporation;
For the treatment of several myelodysplastic syndrome subtypes including refractory and chronic myelomonocytic leukemias, Approved May 2004
Hepatology (Liver, Pancreatic, Gall Bladder)
Xifaxan (rifaximin); Salix Pharmaceuticals;
For the treatment of Travelers' diarrhea caused by noninvasive strains of Escherichia coli, Approved May 2004
Immunology
Ketek (telithromycin); Sanofi-aventis;
For the treatment of infections caused by bronchitis, bacterial sinusitis and Community-acquired pneumonia., Approved April 2004
Tindamax, tinidazole; Presutti Laboratories;
For the treatment of microbial infections, including trichomoniasis, giardiasis, and amebiasis, Approved May, 2004
Xifaxan (rifaximin); Salix Pharmaceuticals;
For the treatment of Travelers' diarrhea caused by noninvasive strains of Escherichia coli, Approved May 2004
Musculoskeletal
Vioxx (rofecoxib); Merck;
For the treatment of rheumatoid arthritis, Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004
Nephrology
Fosrenol, lanthanum carbonate; Shire Pharmaceuticals;
For the treatment of hyperphosphatemia related to kidney dysfunction, Approved October, 2004
Sanctura (trospium chloride); Indevus Pharmaceuticals;
For the treatment of overactive bladder with symptoms of urge urinary incontinence, Approved May, 2004
Sensipar (cinacalcet); Amgen;
For the treatment of secondary hyperparathyroidism and hypercalcemia in parathyroid carcinoma patients, Approved March 2004
Vesicare (solifenacin succinate); Yamanouchi, GlaxoSmithKline;
For the treatment of overactive bladder with symptoms of urge urinary incontinence, Approved November, 2004
Neurology
Apokyn (apomorphine hydrochloride); Mylan Laboratories;
For the treatment of acute, intermittent hypomobility episodes associated with advanced Parkinson’s disease, Approved April, 2004
Lunesta (eszopiclone); Sepracor;
For the treatment of insomnia and sleep maintenance, Approved December 2004
Lyrica (pregabalin); Pfizer;
For the treatment of pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, Approved December 2004
Obstetrics/Gynecology (Women’s Health)
EstroGel (estradiol gel 0.06%); Solvay Pharmaceuticals;
For the treatment of vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, Approved April 2004
Oncology
Alimta (pemetrexed for injection); Eli Lilly;
For the treatment of malignant pleural mesothelioma, Approved February 2004
Avastin (bevacizumab); Genentech;
For the treatment of metastatic carcinoma of the colon or rectum, Approved February 2004
Clolar (clofarabine); Genzyme;
For the treatment of acute lymphoblastic leukemia in pediatric patients, Approved December, 2004
Erbitux (cetuximab); Imclone, Bristol-Myers Squibb;
For the treatment of EGFR-expressing, metastatic colorectal cancer, Approved February 2004
Sensipar (cinacalcet); Amgen;
For the treatment of secondary hyperparathyroidism and hypercalcemia in parathyroid carcinoma patients, Approved March 2004
Tarceva (erlotinib, OSI 774); Genentech, OSI Pharmaceuticals;
For the treatment of advanced refractory metastatic non-small cell lung cancer, Approved November, 2004
Ophthalmology
Macugen (pegaptanib); Pfizer / Eyetech Pharmaceuticals;
For the treatment of wet age-related macular degeneration., Approved December 2004
Pharmacology/Toxicology
Campral (acamprosate calcium); Forest Laboratories;
For the treatment of alcohol dependence and the maintenance of alcohol abstinence, Approved August, 2004
Psychiatry/Psychology
Cymbalta (duloxetine); Eli Lilly;
For the treatment of major depressive disorder, Approved August 2004
Pulmonary/Respiratory Diseases
Ketek (telithromycin); Sanofi-aventis;
For the treatment of infections caused by bronchitis, bacterial sinusitis and Community-acquired pneumonia., Approved April 2004
Spiriva HandiHaler (tiotropium bromide); Boehringer Ingelheim;
For the treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved February 2004
Rheumatology
Vioxx (rofecoxib); Merck;
For the treatment of rheumatoid arthritis, Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004
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.
