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
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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;
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;
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;
For adults with susceptible strains of bacterial infections, Approved November 2001
Cancidas; Merck;
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;
For adults with susceptible strains of bacterial infections, Approved November 2001
Cancidas; Merck;
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;
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;
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
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.
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