Description of Medical Areas

About the FDA Approved Listings

Drugs Approved by the FDA (2003)

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

  • Crestor (rosuvastatin calcium); For the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; AstraZeneca; Approved August 2003
  • Levitra (vardenafil); For the treatment of erectile dysfunction related to sexual activity in men; Bayer, GlaxoSmithKline; Approved September 2003

Dental/Maxillofacial Surgery

    No approvals recorded to date in this area.

Dermatology/Plastic Surgery

Endocrinology

Gastroenterology

  • Aloxi (palonosetron); For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy; MGI Pharma, Helsinn Healthcare; Approved August 2003
  • Emend (aprepitant); For the treatment of nausea and vomiting associated with chemotherapy; Merck; Approved March 2003
  • Oxytrol (oxybutynin transdermal system); For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.; Watson Pharmaceuticals; Approved March 2003

Hematology

  • Bexxar; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following chemotherapy relapse; Corixa; Approved June 2003
  • Levitra (vardenafil); For the treatment of erectile dysfunction related to sexual activity in men; Bayer, GlaxoSmithKline; Approved September 2003
  • Reyataz (atazanavir sulfate); For the treatment of HIV-1 infection in combination with other antiretroviral agents; Bristol-Myers Squibb; Approved July 2003
  • Zemaira (alpha1-proteinase inhibitor); For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-1) and emphysema; Aventis Behring; Approved July 2003

Immunology/Infectious Diseases

  • Amevive (alefacept); For moderate to severe chronic plaque psoriasis.; Biogen; Approved January 2003
  • FluMist ( Influenza Virus Vaccine); For the prevention of disease caused by influenza A and B viruses; MedImmune; Approved June 2003
  • Fuzeon (enfuvirtide); For the treatment of HIV-1 infection in combination with other antiretroviral agents; Trimeris, Roche; Approved March 2003
  • Lexiva (fosamprenavir calcium); For the treatment of HIV infection in adults in combination with other antiretroviral agents.; GlaxoSmithKline; Approved October 2003
  • Reyataz (atazanavir sulfate); For the treatment of HIV-1 infection in combination with other antiretroviral agents; Bristol-Myers Squibb; Approved July 2003

Musculoskeletal

  • Aldurazyme (laronidase); For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65; Genzyme; Approved May 2003
  • Boniva (ibandronate); For the treatment and prevention of osteoporosis; Roche / GlaxoSmithKline; Approved May, 2003 -- UPDATED: NEW FORMULATION APPROVED MARCH, 2005
  • Somavert (pegvisomant); Injectable formulation for the treatment of acromegaly; Pharmacia; Approved March 2003
  • Velcade (bortezomib); Injectable agent for the treatment of multiple myeloma patients who have received at least two prior therapies.; Millennium Pharmaceuticals; Approved May 2003

Nephrology/Urology

Neurology

  • Cialis (tadalafil); Oral agent for the treatment for erectile dysfunction; Eli Lilly; Approved December 2003
  • Levitra (vardenafil); For the treatment of erectile dysfunction related to sexual activity in men; Bayer, GlaxoSmithKline; Approved September 2003
  • Namenda (memantine HCl); For the treatment of moderate to severe dementia of the Alzheimer’s type.; Forest Laboratories; Approved October 2003

Obstetrics/Gynecology

    No approvals recorded to date in this area.

Oncology

  • Aloxi (palonosetron); For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy; MGI Pharma, Helsinn Healthcare; Approved August 2003
  • Bexxar; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following chemotherapy relapse; Corixa; Approved June 2003
  • Emend (aprepitant); For the treatment of nausea and vomiting associated with chemotherapy; Merck; Approved March 2003
  • Iressa (gefitinib); For the second-line treatment of non-small-cell lung cancer; AstraZeneca; Approved May 2003
  • Plenaxis (abarelix for injectable suspension); For treatment of advanced prostate cancer; Praecis Pharmaceuticals; Approved December 2003
  • UroXatral (alfuzosin HCl extended-release tablets); For the treatment of of the signs and symptoms of benign prostatic hyperplasia; Sanofi-Synthelabo; Approved June 2003
  • Velcade (bortezomib); Injectable agent for the treatment of multiple myeloma patients who have received at least two prior therapies.; Millennium Pharmaceuticals; Approved May 2003

Ophthalmology

    No approvals recorded to date in this area.

Otolaryngology

    No approvals recorded to date in this area.

Pediatrics/Neonatology

  • Aldurazyme (laronidase); For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65; Genzyme; Approved May 2003

Pharmacology/Toxicology

    No approvals recorded to date in this area.

Psychiatry/Psychology

    No approvals recorded to date in this area.

Pulmonary/Respiratory Diseases

  • Aldurazyme (laronidase); For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65; Genzyme; Approved May 2003
  • Iressa (gefitinib); For the second-line treatment of non-small-cell lung cancer; AstraZeneca; Approved May 2003
  • Zemaira (alpha1-proteinase inhibitor); For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-1) and emphysema; Aventis Behring; Approved July 2003

Rheumatology

    No approvals recorded to date in this area.

Trauma/Emergency Medicine

    No approvals recorded to date in this area.


Back to Centerwatch Drug Directories



Drug listings last updated: July 3, 2008 at 2:32:28 PM

Copyright © 1995 - 2008, CenterWatch
All Rights Reserved

This site was developed in association with Illumina Interactive, Boston, MA