2003 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
Crestor (rosuvastatin calcium); AstraZeneca;
For the treatment of primary hypercholesterolemia (heterozygous
familial and nonfamilial) and mixed dyslipidemia, Approved August 2003
Levitra (vardenafil); Bayer, GlaxoSmithKline;
For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003
Dermatology
Amevive (alefacept); Biogen IDEC;
For moderate to severe chronic plaque psoriasis., Approved January 2003
Finacea (azelaic acid) Gel, 15%; Berlex Laboratories;
Gel formulation for the treatment of rosacea., January 2003
Endocrinology
Aldurazyme (laronidase); Genzyme;
For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003
Fabrazyme (agalsidase beta); Genzyme;
For the treatment of Fabry disease in adult patients, Approved April 2003
Somavert (pegvisomant); Pfizer;
Injectable formulation for the treatment of acromegaly, Approved March 2003
Family Medicine
Amevive (alefacept); Biogen IDEC;
For moderate to severe chronic plaque psoriasis., Approved January 2003
Cialis (tadalafil); Eli Lilly;
Oral agent for the treatment for erectile dysfunction, Approved December 2003
Finacea (azelaic acid) Gel, 15%; Berlex Laboratories;
Gel formulation for the treatment of rosacea., January 2003
Fuzeon (enfuvirtide); Trimeris, Roche;
For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved March 2003
Iressa (gefitinib); AstraZeneca;
For the second-line treatment of non-small-cell lung cancer, Approved May 2003
Levitra (vardenafil); Bayer, GlaxoSmithKline;
For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003
Lexiva (fosamprenavir calcium); GlaxoSmithKline;
For the treatment of HIV infection in adults in combination with other antiretroviral agents., Approved October 2003
Namenda (memantine HCl); Forest Laboratories;
For the treatment of moderate to severe dementia of the Alzheimer’s type., Approved October 2003
Plenaxis (abarelix for injectable suspension); Praecis Pharmaceuticals;
For treatment of advanced prostate cancer, Approved December 2003
Premarin (conjugated estrogens); Wyeth;
For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003
Reyataz (atazanavir sulfate); Bristol-Myers Squibb;
For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved July 2003
UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis;
For the treatment of of the signs and symptoms of benign prostatic hyperplasia, Approved June 2003
Xolair (omalizumab); Genentech;
For the treatment of asthma, Approved June 2003
Gastroenterology
Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare;
For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, Approved August 2003
Emend (aprepitant); Merck;
For the treatment of nausea and vomiting associated with chemotherapy, Approved March 2003
Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals;
For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency., Approved March 2003
Hematology
Bexxar; Corixa;
For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following chemotherapy relapse, Approved June 2003
Levitra (vardenafil); Bayer, GlaxoSmithKline;
For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003
Reyataz (atazanavir sulfate); Bristol-Myers Squibb;
For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved July 2003
Zemaira (alpha1-proteinase inhibitor); Aventis Behring;
For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-1) and emphysema, Approved July 2003
Immunology
Amevive (alefacept); Biogen IDEC;
For moderate to severe chronic plaque psoriasis., Approved January 2003
FluMist ( Influenza Virus Vaccine); MedImmune;
For the prevention of disease caused by influenza A and B viruses, Approved June 2003
Fuzeon (enfuvirtide); Trimeris, Roche;
For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved March 2003
Lexiva (fosamprenavir calcium); GlaxoSmithKline;
For the treatment of HIV infection in adults in combination with other antiretroviral agents., Approved October 2003
Reyataz (atazanavir sulfate); Bristol-Myers Squibb;
For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved July 2003
Infections and Infectious Diseases
FluMist ( Influenza Virus Vaccine); MedImmune;
For the prevention of disease caused by influenza A and B viruses, Approved June 2003
Fuzeon (enfuvirtide); Trimeris, Roche;
For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved March 2003
Lexiva (fosamprenavir calcium); GlaxoSmithKline;
For the treatment of HIV infection in adults in combination with other antiretroviral agents., Approved October 2003
Reyataz (atazanavir sulfate); Bristol-Myers Squibb;
For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved July 2003
Musculoskeletal
Aldurazyme (laronidase); Genzyme;
For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003
Premarin (conjugated estrogens); Wyeth;
For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003
Somavert (pegvisomant); Pfizer;
Injectable formulation for the treatment of acromegaly, Approved March 2003
Velcade (bortezomib); Millennium Pharmaceuticals;
Injectable agent for the treatment of multiple myeloma patients who have received at least two prior therapies., Approved May 2003
Nephrology
Fabrazyme (agalsidase beta); Genzyme;
For the treatment of Fabry disease in adult patients, Approved April 2003
Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals;
For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency., Approved March 2003
UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis;
For the treatment of of the signs and symptoms of benign prostatic hyperplasia, Approved June 2003
Neurology
Cialis (tadalafil); Eli Lilly;
Oral agent for the treatment for erectile dysfunction, Approved December 2003
Levitra (vardenafil); Bayer, GlaxoSmithKline;
For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003
Namenda (memantine HCl); Forest Laboratories;
For the treatment of moderate to severe dementia of the Alzheimer’s type., Approved October 2003
Obstetrics/Gynecology (Women’s Health)
Premarin (conjugated estrogens); Wyeth;
For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003
Seasonale, Lo Seasonale, Seasonique (ethinylestradiol + levonorgestrel); Duramed Pharmaceuticals;
For the prevention of contraception, Approved September 2003
Oncology
Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare;
For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, Approved August 2003
Bexxar; Corixa;
For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following chemotherapy relapse, Approved June 2003
Emend (aprepitant); Merck;
For the treatment of nausea and vomiting associated with chemotherapy, Approved March 2003
Iressa (gefitinib); AstraZeneca;
For the second-line treatment of non-small-cell lung cancer, Approved May 2003
Plenaxis (abarelix for injectable suspension); Praecis Pharmaceuticals;
For treatment of advanced prostate cancer, Approved December 2003
Premarin (conjugated estrogens); Wyeth;
For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003
UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis;
For the treatment of of the signs and symptoms of benign prostatic hyperplasia, Approved June 2003
Velcade (bortezomib); Millennium Pharmaceuticals;
Injectable agent for the treatment of multiple myeloma patients who have received at least two prior therapies., Approved May 2003
Pediatrics/Neonatology
Aldurazyme (laronidase); Genzyme;
For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003
Pulmonary/Respiratory Diseases
Aldurazyme (laronidase); Genzyme;
For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003
Iressa (gefitinib); AstraZeneca;
For the second-line treatment of non-small-cell lung cancer, Approved May 2003
Xolair (omalizumab); Genentech;
For the treatment of asthma, Approved June 2003
Zemaira (alpha1-proteinase inhibitor); Aventis Behring;
For the treatment of alpha1-proteinase inhibitor deficiency (Alpha-1) and emphysema, Approved July 2003
Urology
Cialis (tadalafil); Eli Lilly;
Oral agent for the treatment for erectile dysfunction, Approved December 2003
Levitra (vardenafil); Bayer, GlaxoSmithKline;
For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003
Plenaxis (abarelix for injectable suspension); Praecis Pharmaceuticals;
For treatment of advanced prostate cancer, Approved December 2003
UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis;
For the treatment of of the signs and symptoms of benign prostatic hyperplasia, Approved June 2003
Vaccines
FluMist ( Influenza Virus Vaccine); MedImmune;
For the prevention of disease caused by influenza A and B viruses, Approved June 2003
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.
