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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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2004

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Vioxx (rofecoxib); Merck; For the treatment of rheumatoid arthritis, Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004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