2001 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

Advicor (extended-release niacin/lovastatin); Kos Pharmaceuticals; For the treatment of cholesterol disorders, Approved December 2001

Diovan (valsartan); Novartis; Oral capsules and tablets for the treatment of hypertension, Approved January 1997 (capsules); July 2001 (tablets)

Natrecor (nesiritide); Scios; For the treatment of patients with acutely decompensated congestive heart failure, Approved August 2001

Teveten (eprosartan mesylate plus hydrochlorothiazide); Unimed Pharmaceuticals; Tablets for the treatment of hypertension, Approved November 2001

Tricor (fenofibrate); Abbott Laboratories; For the treatment of primary hypercholesterolemia, mixed lipidemia and hypertriglyceridemia, Approved September 2001

Dental and Oral Health

Arestin (minocycline hydrochloride); OraPharma; For treatment of adult periodontitis, Approved February 2001

Periostat (doxycycline hyclate); CollaGenex Pharmaceuticals; Oral tablet for adjunctive treatment of adult periodontitis, Approved February 2001

Dermatology

Elidel; Novartis; Topical cream for the treatment of atopic dermatitis, Approved December 2001

Estrostep (norethindrone acetate and ethinyl estradiol); Pfizer; For the treatment of moderate acne vulgaris, Approved July 2001

Finevin; Berlex Laboratories; Topical cream for the treatment of mild to moderate inflammatory acne vulgaris, Approved May 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

Lamisil Solution, 1%; Novartis; Topical treatment for tinea (pityriasis) versicolor, althete's foot, jock itch, and ringworm, Approved March 2001

Endocrinology

Campath; Berlex Laboratories; Injectable treatment of B-cell chronic lymphocytic leukemia, Approved May 2001

Diovan (valsartan); Novartis; Oral capsules and tablets for the treatment of hypertension, Approved January 1997 (capsules); July 2001 (tablets)

Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001

Genotropin (somatropin) injection; Pharmacia & Upjohn; For the treatment of growth failure in children who were born small for gestational age (SGA), Approved July 2001

Gleevec (imatinib mesylate); Novartis; Oral therapy for the treatment of chronic myeloid leukemia, Approved May 2001

Levoxyl; Jones Pharma; Oral therapy for the treatment of hypothyroidism and suppression of thyroid-stimulating hormone (TSH), Approved May 2001

Natrecor (nesiritide); Scios; For the treatment of patients with acutely decompensated congestive heart failure, Approved August 2001

Novolog Mix 70/30; Novo Nordisk; Subcutaneous injection for the control of hyperglycemia, associated with type 1 and 2 diabetes, Approved November 2001

Prozac Weekly (fluoxetine HCl); Eli Lilly; For the treatment of depression, Approved February 2001

Remeron SolTab (mirtazapine); Organon; Orally disintegrating tablet for the treatment of depression, Approved January 2001

Remicade (infliximab); Centocor Ortho Biotech; For inhibiting the progression of structural damage in patients with rheumatoid arthritis, Approved January 2001

Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001

Yasmin (drospirenone/ethinyl estradiol); Berlex Laboratories; Oral contraceptive, Approved May 2001

Zometa (zoledronic acid); Novartis; For the treatment of hypercalcemia of malignancy, Approved August 2001

Family Medicine

Adderall XR; Shire Pharmaceuticals; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD), Approved October 2001

Advicor (extended-release niacin/lovastatin); Kos Pharmaceuticals; For the treatment of cholesterol disorders, Approved December 2001

Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of bacterial infections, Approved November 2001

Axert (almotriptan malate) tablets; Pharmacia & Upjohn; For the treatment of migraine attacks, Approved May 2001

Bayer Extra Strength Asprin; Bayer; Oral treatment for mild to moderate migraine pain, Approved October 2001

Bextra; Pharmacia, Pfizer; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved November 2001

Cancidas; Merck; Intravenous infusion for the treatment of invasive aspergillosis, Approved January 2001

Diovan (valsartan); Novartis; Oral capsules and tablets for the treatment of hypertension, Approved January 1997 (capsules); July 2001 (tablets)

DuoNeb (albuterol sulfate and ipratropium bromide); Dey Laboratories; For the treatment of bronchospasm associated with COPD, Approved March 2001

Dutasteride; GlaxoSmithKline; For the treatment of symptomatic benign prostatic hyperplasia, Approved November 2001

Elidel; Novartis; Topical cream for the treatment of atopic dermatitis, Approved December 2001

Entocort EC (budesonide); AstraZeneca; Capsules for the treatment of mild-to-moderate, active Crohn's disease, Approved October 2001

Estrostep (norethindrone acetate and ethinyl estradiol); Pfizer; For the treatment of moderate acne vulgaris, Approved July 2001

Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001

Finevin; Berlex Laboratories; Topical cream for the treatment of mild to moderate inflammatory acne vulgaris, Approved May 2001

Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001

Foradil Aerolizer (formoterol fumarate inhalation powder); Novartis; Bronchodilator for COPD, asthma and bronchospasm, Approved February 2001 (asthma, bronchospasm); September 2001 (COPD)

Frova (frovatriptan succinate); Elan Pharmaceuticals; Tablets for the acute treatment of migraine attacks, Approved November 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

Kineret; Amgen; Injectable therapy for the treatment of rheumatoid arthritis, Approved November 2001

Lamisil Solution, 1%; Novartis; Topical treatment for tinea (pityriasis) versicolor, althete's foot, jock itch, and ringworm, Approved March 2001

Lumigan (bimatoprost ophthalmic solution); Allergan; For the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Approved March 2001

Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001

Nexium (esomeprazole magnesium); AstraZeneca; For the eradication of Helicobacter pylori, the healing of erosive esophagitis, and the treatment of symptomatic GERD, Approved February 2001

Novolog Mix 70/30; Novo Nordisk; Subcutaneous injection for the control of hyperglycemia, associated with type 1 and 2 diabetes, Approved November 2001

Protonix (pantoprazole sodium) Intravenous Formulation; Wyeth; For the short-term treatment of gastroesophageal reflux disease, Approved March 2001

Prozac Weekly (fluoxetine HCl); Eli Lilly; For the treatment of depression, Approved February 2001

Remeron SolTab (mirtazapine); Organon; Orally disintegrating tablet for the treatment of depression, Approved January 2001

Remicade (infliximab); Centocor Ortho Biotech; For inhibiting the progression of structural damage in patients with rheumatoid arthritis, Approved January 2001

Reminyl (galantamine hydrobromide); Janssen Pharmaceuticals; For the treatment of mild to moderate dementia of the Alzheimer's type, Approved February 2001

Spectracef; TAP Pharmaceuticals; Oral tablets for the treatment of mild to moderate bacterial infections, Approved August 2001

Supartz; Smith & Nephew Orthopaedics; Joint fluid therapy for treatment of osteoarthritis in the knee, Approved January 2001

Tavist (clemastine fumarate); Novartis; Oral tablet for temporary relief of symptoms associated with hay fever, allergic rhinitis, and the common cold, Approved March 2001

Teveten (eprosartan mesylate plus hydrochlorothiazide); Unimed Pharmaceuticals; Tablets for the treatment of hypertension, Approved November 2001

Tracleer (bosentan); Actelion; For the treatment of pulmonary arterial hypertension, Approved November 2001

Travatan (travoprost ophthalmic solution); Alcon; For the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Approved March 2001

Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001

Tricor (fenofibrate); Abbott Laboratories; For the treatment of primary hypercholesterolemia, mixed lipidemia and hypertriglyceridemia, Approved September 2001

Ultracet (acetaminophen and tramadol HCl); Ortho-McNeil Pharmaceutical; For the short-term management of acute pain, Approved August 2001

Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March 2001

Ventolin HFA (albuterol sulfate inhalation aerosol); GlaxoSmithKline; For the treatment or prevention of bronchospasm, Approved April 2001

Viread (tenofovir disoproxil fumarate); Gilead; Once-daily oral tablet for the treatment of human immunodeficiency virus (HIV) infection, Approved October 2001

Zomig (zolmitriptan); AstraZeneca; Orally disintegrating tablet for the treatment of acute migraine in adults, Approved February 2001

Gastroenterology

Canasa (mesalamine); Axcan; For the treatment of active ulcerative proctitis, Approved January 2001

Entocort EC (budesonide); AstraZeneca; Capsules for the treatment of mild-to-moderate, active Crohn's disease, Approved October 2001

Nexium (esomeprazole magnesium); AstraZeneca; For the eradication of Helicobacter pylori, the healing of erosive esophagitis, and the treatment of symptomatic GERD, Approved February 2001

Protonix (pantoprazole sodium) Intravenous Formulation; Wyeth; For the short-term treatment of gastroesophageal reflux disease, Approved March 2001

Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001

Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001

Hematology

Arixtra; Organon, Sanofi-Synthelabo; Injectable solution for the prevention of deep vein thrombosis, Approved December 2001

Hepatology (Liver, Pancreatic, Gall Bladder)

Peg-Intron (peginterferon alfa-2b); Schering-Plough; For the treatment of chronic hepatitis C, Approved January 2001

Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001

Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001

Immunology

Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of bacterial infections, Approved November 2001

Cancidas; Merck; Intravenous infusion for the treatment of invasive aspergillosis, Approved January 2001

Peg-Intron (peginterferon alfa-2b); Schering-Plough; For the treatment of chronic hepatitis C, Approved January 2001

Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001

Spectracef; TAP Pharmaceuticals; Oral tablets for the treatment of mild to moderate bacterial infections, Approved August 2001

Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001

Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March 2001

Viread (tenofovir disoproxil fumarate); Gilead; Once-daily oral tablet for the treatment of human immunodeficiency virus (HIV) infection, Approved October 2001

Xigris (drotrecogin alfa [activated]); Eli Lilly; For the treatment of severe sepsis, Approved November 2001

Infections and Infectious Diseases

Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of bacterial infections, Approved November 2001

Cancidas; Merck; Intravenous infusion for the treatment of invasive aspergillosis, Approved January 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

Lamisil Solution, 1%; Novartis; Topical treatment for tinea (pityriasis) versicolor, althete's foot, jock itch, and ringworm, Approved March 2001

NasalCrom Nasal Spray; Pharmacia & Upjohn; Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved April 2001

Peg-Intron (peginterferon alfa-2b); Schering-Plough; For the treatment of chronic hepatitis C, Approved January 2001

Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001

Spectracef; TAP Pharmaceuticals; Oral tablets for the treatment of mild to moderate bacterial infections, Approved August 2001

Tavist (clemastine fumarate); Novartis; Oral tablet for temporary relief of symptoms associated with hay fever, allergic rhinitis, and the common cold, Approved March 2001

Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001

Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March 2001

Viread (tenofovir disoproxil fumarate); Gilead; Once-daily oral tablet for the treatment of human immunodeficiency virus (HIV) infection, Approved October 2001

Xigris (drotrecogin alfa [activated]); Eli Lilly; For the treatment of severe sepsis, Approved November 2001

Musculoskeletal

Genotropin (somatropin) injection; Pharmacia & Upjohn; For the treatment of growth failure in children who were born small for gestational age (SGA), Approved July 2001

Kineret; Amgen; Injectable therapy for the treatment of rheumatoid arthritis, Approved November 2001

Supartz; Smith & Nephew Orthopaedics; Joint fluid therapy for treatment of osteoarthritis in the knee, Approved January 2001

Nephrology

Dutasteride; GlaxoSmithKline; For the treatment of symptomatic benign prostatic hyperplasia, Approved November 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

PhosLo; Braintree Laboratories; Oral capsules and gelcaps for the control of hyperphosphatemia in end stage renal failure, Approved April 2001

Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001

Neurology

Axert (almotriptan malate) tablets; Pharmacia & Upjohn; For the treatment of migraine attacks, Approved May 2001

Bayer Extra Strength Asprin; Bayer; Oral treatment for mild to moderate migraine pain, Approved October 2001

Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001

Frova (frovatriptan succinate); Elan Pharmaceuticals; Tablets for the acute treatment of migraine attacks, Approved November 2001

Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001

Reminyl (galantamine hydrobromide); Janssen Pharmaceuticals; For the treatment of mild to moderate dementia of the Alzheimer's type, Approved February 2001

Ultracet (acetaminophen and tramadol HCl); Ortho-McNeil Pharmaceutical; For the short-term management of acute pain, Approved August 2001

Zomig (zolmitriptan); AstraZeneca; Orally disintegrating tablet for the treatment of acute migraine in adults, Approved February 2001

Obstetrics/Gynecology (Women’s Health)

Bextra; Pharmacia, Pfizer; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved November 2001

Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

Monistat 3 (miconazole nitrate); Advanced Care Products; Emulsion, cream for the treatment of vaginal yeast infections, Approved February 2001

NuvaRing; Organon; Monthly vaginal ring for birth control, Approved October 2001

Ortho Evra; Ortho-McNeil Pharmaceutical; Transdermal patch for contraception, Approved November 2001

Yasmin (drospirenone/ethinyl estradiol); Berlex Laboratories; Oral contraceptive, Approved May 2001

Oncology

Campath; Berlex Laboratories; Injectable treatment of B-cell chronic lymphocytic leukemia, Approved May 2001

Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001

Gleevec (imatinib mesylate); Novartis; Oral therapy for the treatment of chronic myeloid leukemia, Approved May 2001

Kytril (granisetron) solution; Roche; For the prevention of nausea and vomiting associated with cancer therapy, Approved June 2001

Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001

Xeloda; Roche; Oral chemotherapy for the treatment of metastatic colorectal cancer, Approved May 2001

Zometa (zoledronic acid); Novartis; For the treatment of hypercalcemia of malignancy, Approved August 2001

Ophthalmology

Lumigan (bimatoprost ophthalmic solution); Allergan; For the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Approved March 2001

Travatan (travoprost ophthalmic solution); Alcon; For the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Approved March 2001

Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March 2001

Pediatrics/Neonatology

Adderall XR; Shire Pharmaceuticals; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD), Approved October 2001

Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001

Genotropin (somatropin) injection; Pharmacia & Upjohn; For the treatment of growth failure in children who were born small for gestational age (SGA), Approved July 2001

Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001

NasalCrom Nasal Spray; Pharmacia & Upjohn; Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved April 2001

Psychiatry/Psychology

Adderall XR; Shire Pharmaceuticals; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD), Approved October 2001

Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001

Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001

Prozac Weekly (fluoxetine HCl); Eli Lilly; For the treatment of depression, Approved February 2001

Remeron SolTab (mirtazapine); Organon; Orally disintegrating tablet for the treatment of depression, Approved January 2001

Ziprasidone (ziprasidone hydrochloride); Pfizer; Oral capsule for the treatment of schizophrenia, Approved February 2001

Pulmonary/Respiratory Diseases

Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of bacterial infections, Approved November 2001

DuoNeb (albuterol sulfate and ipratropium bromide); Dey Laboratories; For the treatment of bronchospasm associated with COPD, Approved March 2001

Foradil Aerolizer (formoterol fumarate inhalation powder); Novartis; Bronchodilator for COPD, asthma and bronchospasm, Approved February 2001 (asthma, bronchospasm); September 2001 (COPD)

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

NasalCrom Nasal Spray; Pharmacia & Upjohn; Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved April 2001

Tavist (clemastine fumarate); Novartis; Oral tablet for temporary relief of symptoms associated with hay fever, allergic rhinitis, and the common cold, Approved March 2001

Tracleer (bosentan); Actelion; For the treatment of pulmonary arterial hypertension, Approved November 2001

Ventolin HFA (albuterol sulfate inhalation aerosol); GlaxoSmithKline; For the treatment or prevention of bronchospasm, Approved April 2001

Rheumatology

Bextra; Pharmacia, Pfizer; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved November 2001

Kineret; Amgen; Injectable therapy for the treatment of rheumatoid arthritis, Approved November 2001

Remicade (infliximab); Centocor Ortho Biotech; For inhibiting the progression of structural damage in patients with rheumatoid arthritis, Approved January 2001

Supartz; Smith & Nephew Orthopaedics; Joint fluid therapy for treatment of osteoarthritis in the knee, Approved January 2001

Urology

Dutasteride; GlaxoSmithKline; For the treatment of symptomatic benign prostatic hyperplasia, Approved November 2001

Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001

Vaccines

Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of bacterial infections, Approved November 2001

Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001

Spectracef; TAP Pharmaceuticals; Oral tablets for the treatment of mild to moderate bacterial infections, Approved August 2001

Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001