Description of Medical Areas

About the FDA Approved Listings

Drugs Approved by the FDA (2004)

Approval Year: 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 | 1995 | All Years


The following drugs have been approved this year by the Food and Drug Administration.

Cardiology/Vascular Diseases

Dental/Maxillofacial Surgery

    No approvals recorded to date in this area.

Dermatology/Plastic Surgery

    No approvals recorded to date in this area.

Endocrinology

    No approvals recorded to date in this area.

Gastroenterology

  • Avastin (bevacizumab); For the treatment of metastatic carcinoma of the colon or rectum; Genentech; Approved February 2004
  • Erbitux (cetuximab); For the treatment of EGFR-expressing, metastatic colorectal cancer; Imclone, Bristol-Myers Squibb; Approved February 2004

Hematology

  • Vidaza (azacitidine); For the treatment of several myelodysplastic syndrome subtypes including refractory and chronic myelomonocytic leukemias; Pharmion Corporation; Approved May 2004

Immunology/Infectious Diseases

  • Ketek (telithromycin); For the treatment of infections caused by bronchitis, bacterial sinusitis and Community-acquired pneumonia.; Aventis Pharmaceuticals; Approved April 2004
  • Tindamax, tinidazole; For the treatment of microbial infections, including trichomoniasis, giardiasis, and amebiasis; Presutti Laboratories; Approved May, 2004
  • Xifaxan (rifaximin); For the treatment of Travelers' diarrhea caused by noninvasive strains of Escherichia coli; Salix Pharmaceuticals; Approved May 2004

Musculoskeletal

  • Vioxx (rofecoxib); For the treatment of rheumatoid arthritis; Merck; Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004

Nephrology/Urology

  • Fosrenol, lanthanum carbonate; For the treatment of hyperphosphatemia related to kidney dysfunction; Shire Pharmaceuticlas; Approved October, 2004
  • Sanctura (trospium chloride); For the treatment of overactive bladder with symptoms of urge urinary incontinence; Indevus Pharmaceuticals; Approved May, 2004
  • Sensipar (cinacalcet); For the treatment of secondary hyperparathyroidism and hypercalcemia in parathyroid carcinoma patients; Amgen; Approved March 2004
  • Vesicare (solifenacin succinate); For the treatment of overactive bladder with symptoms of urge urinary incontinence; Yamanouchi, GlaxoSmithKline; Approved November, 2004

Neurology

  • Apokyn (apomorphine hydrochloride); For the treatment of acute, intermittent hypomobility episodes associated with advanced Parkinson’s disease; Mylan Bertek Pharmaceuticals; Approved April, 2004
  • Lunesta (eszopiclone); For the treatment of insomnia and sleep maintenance; Sepracor; Approved December 2004
  • Lyrica (pregabalin); For the treatment of pain associated with diabetic peripheral neuropathy and postherpetic neuralgia; Pfizer; Approved December 2004
  • TYSABRI (natalizumab); For the treatment of relapsing forms of multiple sclerosis; Elan Pharmaceuticals / Biogen Idec; Approved November 2004 -- Updated: Suspended February 2005--Updated: sBLA

Obstetrics/Gynecology

  • EstroGel (estradiol gel 0.06%); For the treatment of vasomotor symptoms and vulvar and vaginal atrophy associated with menopause; Solvay Pharmaceuticals; Approved April 2004

Oncology

  • Alimta (pemetrexed for injection); For the treatment of malignant pleural mesothelioma; Eli Lilly; Approved February 2004
  • Avastin (bevacizumab); For the treatment of metastatic carcinoma of the colon or rectum; Genentech; Approved February 2004
  • Clolar (clofarabine); For the treatment of acute lymphoblastic leukemia in pediatric patients; Genzyme; Approved December, 2004
  • Erbitux (cetuximab); For the treatment of EGFR-expressing, metastatic colorectal cancer; Imclone, Bristol-Myers Squibb; Approved February 2004
  • Sensipar (cinacalcet); For the treatment of secondary hyperparathyroidism and hypercalcemia in parathyroid carcinoma patients; Amgen; Approved March 2004
  • Tarceva (erlotinib, OSI 774); For the treatment of advanced refractory metastatic non-small cell lung cancer; Genentech, OSI Pharmaceuticals; Approved November, 2004

Ophthalmology

  • Macugen (pegaptanib); For the treatment of wet age-related macular degeneration.; Pfizer / Eyetech Pharmaceuticals; Approved December 2004

Otolaryngology

    No approvals recorded to date in this area.

Pediatrics/Neonatology

    No approvals recorded to date in this area.

Pharmacology/Toxicology

  • Campral (acamprosate calcium); For the treatment of alcohol dependence and the maintenance of alcohol abstinence; Forest Laboratories; Approved August, 2004

Psychiatry/Psychology

Pulmonary/Respiratory Diseases

  • Ketek (telithromycin); For the treatment of infections caused by bronchitis, bacterial sinusitis and Community-acquired pneumonia.; Aventis Pharmaceuticals; Approved April 2004
  • Spiriva HandiHaler (tiotropium bromide); For the treatment of bronchospasm associated with chronic obstructive pulmonary disease; Boehringer Ingelheim; Approved February 2004

Rheumatology

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

Trauma/Emergency Medicine

    No approvals recorded to date in this area.


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Drug listings last updated: September 5, 2008 at 3:56:16 PM

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