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); Pharmacia & Upjohn; 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); Pharmacia & Upjohn; 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