2002 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
Altocor (lovastatin) Extended-Release Tablets; Andrx;
Oral tablets for the adjuctive treatment of hypercholesterolemia, Approved June 2002
Benicar; Daiichi Sankyo;
Oral tablet for the treatment of hypertension, Approved April 2002
Imagent (perflexane lipid microspheres); Alliance Pharmaceutical;
Ultrasound contrast agent for improved imaging of the heart, Approved June 2002
Inspra (eplerenone tablets); Pharmacia & Upjohn;
Oral tablets for the treatment of high blood pressure., Approved September 2002
Plavix (clopidogrel bisulfate); Sanofi-aventis;
For the treatment of acute coronary syndrome, Approved February 2002
Remodulin (treprostinil); United Therapeutics;
For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms, Approved May 2002
Dermatology
Botox Cosmetic (botulinum toxin type A); Allergan;
For the temporary improvement in the appearance of glabellar lines (brow furrow), Approved April 2002
Endocrinology
Avandamet (rosiglitazone maleate and metformin HCl); GlaxoSmithKline;
For improvement of glycemic control in type 2 diabetes patients, Approved October 2002
Benicar; Daiichi Sankyo;
Oral tablet for the treatment of hypertension, Approved April 2002
Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals;
Human-derived follicle-stimulating hormone (hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002
Forteo (teriparatide); Eli Lilly;
For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002
Levo-T (levothyroxine sodium); Mova Pharmaceutical;
Indicated for the treatment of hypothyroidism and the suppression of thyroid stimulating hormone, Approved March 2002
Metaglip (glipizide/metformin HCl); Bristol-Myers Squibb;
Oral tablets for the treatment of type 2 diabetes., Approved October 2002
Novothyrox (levothyroxine sodium); Genpharm;
For the treatment of hypothyroidism and suppression of thyroid-stimulating hormone, Approved May 2002
Synthroid (levothyroxine sodium); Abbott Laboratories;
For replacement or supplemental therapy for hypothyroidism and pituitary thyroid stimulating hormone suppression, Approved July 2002
Testim; Auxilium Pharmaceuticals;
External cream for the treatment of male hormone deficiency., Approved October 2002
Family Medicine
Aciphex (rabeprazole sodium); Elan Pharmaceuticals;
For the treatment of symptomatic gastroesophageal reflux disease, Approved February 2002
Alora; Watson Pharmaceuticals;
Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms, Approved April 2002
Avandamet (rosiglitazone maleate and metformin HCl); GlaxoSmithKline;
For improvement of glycemic control in type 2 diabetes patients, Approved October 2002
Avinza (morphine sulfate); Elan Pharmaceuticals;
Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy, Approved March 2002
Benicar; Daiichi Sankyo;
Oral tablet for the treatment of hypertension, Approved April 2002
Botox Cosmetic (botulinum toxin type A); Allergan;
For the temporary improvement in the appearance of glabellar lines (brow furrow), Approved April 2002
Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals;
Human-derived follicle-stimulating hormone (hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002
Eligard (leuprolide acetate); Atrix Laboratories;
For the palliative treatment of advanced prostate cancer, Approved January 2002
Enbrel (etanercept); Immunex;
For the treatment of psoriatic arthritis, Approved January 2002
Faslodex (fulvestrant); AstraZeneca;
For the treatment of hormone receptor positive metastatic breast cancer, Approved April 2002
Forteo (teriparatide); Eli Lilly;
For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002
Humira (adalimumab); Abbott Laboratories;
For the treatment of moderately to severely active rheumatoid arthritis, Approved December 2002
Inspra (eplerenone tablets); Pharmacia & Upjohn;
Oral tablets for the treatment of high blood pressure., Approved September 2002
Lexapro (escitalopram oxalate); Forest Laboratories;
An orally administered selective serotonin reuptake inhibitor useful for the treatment for major depressive disorder, Approved August 2002
Metaglip (glipizide/metformin HCl); Bristol-Myers Squibb;
Oral tablets for the treatment of type 2 diabetes., Approved October 2002
Paxil CR (paroxetine hydrochloride); GlaxoSmithKline;
Oral tablet for the treatment of depression and panic disorder, Approved February 2002
Qvar (beclomethasone dipropionate); Ivax;
For the treatment of asthma, Approved May 2002
Rebif (interferon beta-1a); Serono Laboratories;
Subcutaneous injection for the treatment of relapsing forms of multiple sclerosis, Approved March 2002
Relpax (eletriptan hydrobromide); Pfizer;
For the acute treatment of migraine headaches, Approved December 2002
Remicade (infliximab); Centocor Ortho Biotech;
Intravenous infusion for the treatment of rheumatoid arthritis, Approved February 2002
Remodulin (treprostinil); United Therapeutics;
For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms, Approved May 2002
Ritalin LA (methylphenidate HCl); Novartis;
Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD), Approved June 2002
Strattera (atomoxetine HCl); Eli Lilly;
For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002
Sustiva; Bristol-Myers Squibb;
Once-daily oral tablet for the the treatment of HIV infection, Approved February 2002
Vfend (voriconazole); Pfizer;
For the treatment of fungal infections, Approved May 2002
Zelnorm (tegaserod maleate) Tablets; Novartis;
For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation, Approved July 2002
Gastroenterology
Aciphex (rabeprazole sodium); Elan Pharmaceuticals;
For the treatment of symptomatic gastroesophageal reflux disease, Approved February 2002
Alinia (nitazoxanide); Romark Laboratories;
For the treatment Diarrhea caused by Cryptosporidium and Giardia in children., December 2002
Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); Sanofi-aventis;
For the treatment of colon or rectum carcinomas, Approved August 2002
Gleevec (imatinib mesylate); Novartis;
For the treatment of gastrointestinal stromal tumors (GISTs), Approved February 2002
Hepsera (adefovir dipivoxil); Gilead;
For the treatment of chronic hepatitis B in adults with evidence of active viral replication, Approved September 2002
Orfadin (nitisinone); Orphan Pharmaceuticals;
Capsules for the treatment of hereditary tyrosinemia type I, Approved January 2002
Pegasys (peginterferon alfa-2a); Roche;
For the treatment of chronic hepatitis C who have compensated liver disease, Approved October 2002
Protonix (pantoprazole sodium) Delayed Release Tablets; Wyeth;
Oral tablets for the treatment of gastroesophageal and pathological hypersecretory conditions, Approved April 2002
SecreFlo (secretin); Repligen;
To aid in the diagnosis of pancreatic dysfunction and gastrinoma, Approved April 2002
Zelnorm (tegaserod maleate) Tablets; Novartis;
For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation, Approved July 2002
Hematology
Neulasta; Amgen;
Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy, Approved January 2002
Hepatology (Liver, Pancreatic, Gall Bladder)
Hepsera (adefovir dipivoxil); Gilead;
For the treatment of chronic hepatitis B in adults with evidence of active viral replication, Approved September 2002
Pediarix Vaccine; GlaxoSmithKline;
For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002
Pegasys (peginterferon alfa-2a); Roche;
For the treatment of chronic hepatitis C who have compensated liver disease, Approved October 2002
Protonix (pantoprazole sodium) Delayed Release Tablets; Wyeth;
Oral tablets for the treatment of gastroesophageal and pathological hypersecretory conditions, Approved April 2002
Immunology
Alinia (nitazoxanide); Romark Laboratories;
For the treatment Diarrhea caused by Cryptosporidium and Giardia in children., December 2002
Clarinex; Schering-Plough;
Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria, Approved February 2002
Daptacel; Sanofi Pasteur;
Pediatric vaccine for immunization against diptheria, tetanus and pertussis, Approved May 2002
Fluzone Preservative-free; Sanofi Pasteur;
Preservative free, pediatric dose, influenza virus vaccine for the immunization of infants, Approved September 2002
Hepsera (adefovir dipivoxil); Gilead;
For the treatment of chronic hepatitis B in adults with evidence of active viral replication, Approved September 2002
Pediarix Vaccine; GlaxoSmithKline;
For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002
Pegasys (peginterferon alfa-2a); Roche;
For the treatment of chronic hepatitis C who have compensated liver disease, Approved October 2002
Restasis (cyclosporine ophthalmic emulsion); Allergan;
For the treatment of low tear production., December 2002
Sustiva; Bristol-Myers Squibb;
Once-daily oral tablet for the the treatment of HIV infection, Approved February 2002
Vfend (voriconazole); Pfizer;
For the treatment of fungal infections, Approved May 2002
Infections and Infectious Diseases
Botox Cosmetic (botulinum toxin type A); Allergan;
For the temporary improvement in the appearance of glabellar lines (brow furrow), Approved April 2002
Clarinex; Schering-Plough;
Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria, Approved February 2002
Hepsera (adefovir dipivoxil); Gilead;
For the treatment of chronic hepatitis B in adults with evidence of active viral replication, Approved September 2002
Pediarix Vaccine; GlaxoSmithKline;
For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002
Pegasys (peginterferon alfa-2a); Roche;
For the treatment of chronic hepatitis C who have compensated liver disease, Approved October 2002
Sustiva; Bristol-Myers Squibb;
Once-daily oral tablet for the the treatment of HIV infection, Approved February 2002
Vfend (voriconazole); Pfizer;
For the treatment of fungal infections, Approved May 2002
Zelnorm (tegaserod maleate) Tablets; Novartis;
For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation, Approved July 2002
Musculoskeletal
Alora; Watson Pharmaceuticals;
Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms, Approved April 2002
Avinza (morphine sulfate); Elan Pharmaceuticals;
Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy, Approved March 2002
Forteo (teriparatide); Eli Lilly;
For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002
Remicade (infliximab); Centocor Ortho Biotech;
Intravenous infusion for the treatment of rheumatoid arthritis, Approved February 2002
Testim; Auxilium Pharmaceuticals;
External cream for the treatment of male hormone deficiency., Approved October 2002
Vivelle-Dot (estradiol transdermal system); Novartis;
For the prevention of post-menopausal osteoporosis, Approved May 2002
Nephrology
Eligard (leuprolide acetate); Atrix Laboratories;
For the palliative treatment of advanced prostate cancer, Approved January 2002
Mesnex; Bristol-Myers Squibb, Baxter Healthcare;
Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide), Approved March 2002
Neurology
Avinza (morphine sulfate); Elan Pharmaceuticals;
Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy, Approved March 2002
Neurontin (gabapentin); Pfizer;
Oral treatment for the management of post-herpetic neuralgia (PHN), Approved May 2002
Rebif (interferon beta-1a); Serono Laboratories;
Subcutaneous injection for the treatment of relapsing forms of multiple sclerosis, Approved March 2002
Relpax (eletriptan hydrobromide); Pfizer;
For the acute treatment of migraine headaches, Approved December 2002
Strattera (atomoxetine HCl); Eli Lilly;
For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002
Xyrem (sodium oxybate); Orphan Medical;
For the treatment of cataplexy, a sudden loss of muscle tone, associated with narcolepsy, Approved July 2002
Obstetrics/Gynecology (Women’s Health)
Alora; Watson Pharmaceuticals;
Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms, Approved April 2002
Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals;
Human-derived follicle-stimulating hormone (hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002
Forteo (teriparatide); Eli Lilly;
For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002
Vivelle-Dot (estradiol transdermal system); Novartis;
For the prevention of post-menopausal osteoporosis, Approved May 2002
Zoloft (sertraline HCl); Pfizer;
Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD), Approved May 2002
Oncology
Eligard (leuprolide acetate); Atrix Laboratories;
For the palliative treatment of advanced prostate cancer, Approved January 2002
Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); Sanofi-aventis;
For the treatment of colon or rectum carcinomas, Approved August 2002
Faslodex (fulvestrant); AstraZeneca;
For the treatment of hormone receptor positive metastatic breast cancer, Approved April 2002
Gleevec (imatinib mesylate); Novartis;
For the treatment of gastrointestinal stromal tumors (GISTs), Approved February 2002
Neulasta; Amgen;
Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy, Approved January 2002
SecreFlo (secretin); Repligen;
To aid in the diagnosis of pancreatic dysfunction and gastrinoma, Approved April 2002
Zevalin (ibritumomab tiuxetan); Biogen IDEC;
For the treatment of non-Hodgkin's lymphoma, Approved February 2002
Zometa (zoledronic acid); Novartis;
For the treatment of multiple myeloma and bone metastases from solid tumors, Approved February 2002
Ophthalmology
Restasis (cyclosporine ophthalmic emulsion); Allergan;
For the treatment of low tear production., December 2002
Pediatrics/Neonatology
Alinia (nitazoxanide); Romark Laboratories;
For the treatment Diarrhea caused by Cryptosporidium and Giardia in children., December 2002
Daptacel; Sanofi Pasteur;
Pediatric vaccine for immunization against diptheria, tetanus and pertussis, Approved May 2002
Fluzone Preservative-free; Sanofi Pasteur;
Preservative free, pediatric dose, influenza virus vaccine for the immunization of infants, Approved September 2002
Orfadin (nitisinone); Orphan Pharmaceuticals;
Capsules for the treatment of hereditary tyrosinemia type I, Approved January 2002
Pediarix Vaccine; GlaxoSmithKline;
For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002
Qvar (beclomethasone dipropionate); Ivax;
For the treatment of asthma, Approved May 2002
Ritalin LA (methylphenidate HCl); Novartis;
Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD), Approved June 2002
Strattera (atomoxetine HCl); Eli Lilly;
For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002
Pharmacology/Toxicology
Mesnex; Bristol-Myers Squibb, Baxter Healthcare;
Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide), Approved March 2002
Subutex/Suboxone (buprenorphine/naloxone); Reckitt Benckiser;
Oral tablets for the treatment of opiate dependence, Approved October 2002
Psychiatry/Psychology
Abilify (aripiprazole); Bristol-Myers Squibb, Otsuka America Pharmaceutical;
Oral drug for the treatment of schizophrenia, Approved November 2002
Geodon (ziprasidone mesylate); Pfizer;
To control agitated behavior and psychotic symptoms in schizophrenia patients, Approved June 2002
Lexapro (escitalopram oxalate); Forest Laboratories;
An orally administered selective serotonin reuptake inhibitor useful for the treatment for major depressive disorder, Approved August 2002
Paxil CR (paroxetine hydrochloride); GlaxoSmithKline;
Oral tablet for the treatment of depression and panic disorder, Approved February 2002
Ritalin LA (methylphenidate HCl); Novartis;
Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD), Approved June 2002
Strattera (atomoxetine HCl); Eli Lilly;
For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002
Subutex/Suboxone (buprenorphine/naloxone); Reckitt Benckiser;
Oral tablets for the treatment of opiate dependence, Approved October 2002
Zoloft (sertraline HCl); Pfizer;
Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD), Approved May 2002
Pulmonary/Respiratory Diseases
Clarinex; Schering-Plough;
Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria, Approved February 2002
Qvar (beclomethasone dipropionate); Ivax;
For the treatment of asthma, Approved May 2002
Remodulin (treprostinil); United Therapeutics;
For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms, Approved May 2002
Xopenex; Sepracor;
Inhaled solution for treatment of reversible obstructive airway disease, Approved February 2002
Rheumatology
Enbrel (etanercept); Immunex;
For the treatment of psoriatic arthritis, Approved January 2002
Humira (adalimumab); Abbott Laboratories;
For the treatment of moderately to severely active rheumatoid arthritis, Approved December 2002
Remicade (infliximab); Centocor Ortho Biotech;
Intravenous infusion for the treatment of rheumatoid arthritis, Approved February 2002
Urology
Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals;
Human-derived follicle-stimulating hormone (hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002
Eligard (leuprolide acetate); Atrix Laboratories;
For the palliative treatment of advanced prostate cancer, Approved January 2002
Vaccines
Fluzone Preservative-free; Sanofi Pasteur;
Preservative free, pediatric dose, influenza virus vaccine for the immunization of infants, Approved September 2002
Neurontin (gabapentin); Pfizer;
Oral treatment for the management of post-herpetic neuralgia (PHN), Approved May 2002
Pediarix Vaccine; GlaxoSmithKline;
For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002
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.