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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.
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Find out more about the types of drugs included in this listing.
1996
Cardiology/Vascular Diseases
Covera-HS (verapamil); G.D. Searle, Alza;
Treatment for hypertension and angina, Approved January 1996
Lipitor (atorvastatin calcium); Pfizer;
For the prevention of cardiovascular disease and treatment of hyperlipidemia and dyslipidemia, Approved December 1996
Mavik (trandolapril); Knoll Pharmaceutical;
Treatment for hypertension, Approved May 1996
Muse; Vivus;
Treatment for impotence, Approved October 1996
Pravachol (pravastatin sodium); Bristol-Myers Squibb;
Treatment for cholesterol-lowering, Approved July 1996
Pravachol (pravastatin sodium); Bristol-Myers Squibb;
Treatment for heart disease, Approved April 1996
ProAmatine (midodrine); Roberts Pharmaceutical;
Treatment for hypotension, Approved September 1996
Procanbid (procainamide hydrochloride extended-release tablets); Warner-Lambert;
Treatment for ventricular arrhythmias, Approved January 1996
Retavase (reteplase); Boehringer Mannheim Corporation;
Treatment for patients suffering from heart attack, Approved November 1996
Teczem (enalapril maleate/diltiazem malate); Hoechst Marion Roussel;
Treatment for hypertension, Approved October 1996
Tiazac (diltiazem hydrochloride); Forest Laboratories;
Treatment for hypertension, Approved February 1996
Visipaque (iodixanol); Nycomed;
Diagnostic contrast agent, Approved April 1996
Dental and Oral Health
DentiPatch (lidocaine transoral delivery system); Noven Pharmaceuticals;
Dental anesthetic patch, Approved May 1996
Dermatology
Differin (adapalene gel) Gel, 0.1%; Galderma Laboratories;
Treatment for acne, Approved June 1996
Iamin; ProCyte;
Gel wound dressing, Approved February 1996
Iontocaine; Iomed;
Needle-free anesthetic, Approved May 1996
IvyBlock; EnviroDerm Pharmaceuticals;
Treatment for poison ivy, poison oak, and poison sumac, Approved September 1996
Endocrinology
Aredia (pamidronate disodium for injection); Chiron;
Treatment for osteolytic bone metastases of breast cancer, Approved August 1996
Arimidex (anastrozole); AstraZeneca;
Treatment for advanced breast cancer in postmenopausal women, Approved January 1996
Azulfidine EN-tabs Tablets (sulfasalazine delayed release tablets, USP); Pharmacia & Upjohn;
Treatment for rheumatoid arthritis, Approved October 1996
Campostar; Pharmacia & Upjohn;
Treatment for metastatic colorectal cancer, Approved June 1996
CEA-Scan; Immunomedics;
Diagnostic imaging product for colorectal cancer, Approved April 1996
Confide; Johnson & Johnson;
HIV testing and counseling service, Approved May 1996
Covera-HS (verapamil); G.D. Searle, Alza;
Treatment for hypertension and angina, Approved January 1996
Desmopressin Acetate (DDAVP); Rhone Poulenc Rorer;
Treatment for central diabetes insipidus, Approved February 1996
Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection); Orphan Medical;
Treatment of meningeal leukemia or lymphocytic lymphoma, Approved October 1996
Estrostep (norethindrone acetate and ethinyl estradiol); Parke-Davis;
Treatment for birth control, Approved October 1996
Eulexin (flutamide); Schering-Plough;
Treatment for prostate cancer, Approved June 1996
FemPatch; Parke-Davis;
Treatment for menopausal symptoms, Approved December 1996
Fertinex (urofollitropin for injection, purified); Serono Laboratories;
Treatment for patients undergoing infertility treatments, Approved September 1996
Gemzar (gemcitabine HCL); Eli Lilly;
Treatment for pancreatic cancer, Approved May 1996
Glyset (miglitol); Bayer;
Treatment for Type II (non-insulin-dependent) diabetes mellitus, Approved December 1996
Humalog (insulin lispro); Eli Lilly;
Treatment for type I and type II diabetes, Approved June 1996
Humatrope (somatropin [rDNA origin] for injection); Eli Lilly;
Treatment for Somatropin Deficiency Syndrome, Approved August 1996
Hycamtin (topotecan hydrochloride); SmithKline Beecham;
Treatment for metastatic ovarian cancer, Approved May 1996
Lithobid (Lithium Carbonate); Solvay Pharmaceuticals;
Treatment for manic depression, Approved January 1996
Lodine (etodolac); Wyeth;
Treatment for rheumatoid arthritis, Approved July 1996
Lupron Depot (leuprolide acetate for depot suspension); Abbott Laboratories;
Treatment for advanced prostate cancer, Approved January 1996
Mavik (trandolapril); Knoll Pharmaceutical;
Treatment for hypertension, Approved May 1996
Naprelan (naproxen sodium); Elan Pharmaceuticals, Wyeth;
Treatment for osteoarthritis and rheumatoid arthritis, Approved January 1996
Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals;
Treatment for vitamin B-12 deficiency, Approved November 1996
Nutropin (somatropin-rDNA origin); Genentech;
Treatment that consists of recombinant growth hormone product, Approved January 1996
OxyContin (oxycodone HCl controlled-release); Purdue Pharma;
Treatment for pain associated with musculoskeletal conditions, Approved May 1996
Pravachol (pravastatin sodium); Bristol-Myers Squibb;
Treatment for cholesterol-lowering, Approved July 1996
Redux (dexfenfluramine hydrochloride); Wyeth;
Treatment for obesity, Approved May 1996
Remeron (Mirtazapine); Organon;
Treatment for depression, Approved June 1996
Saizen; Ares-Serono;
Treatment for growth hormone deficiency and Turner Syndrome, Approved May 1996
Taxotere (Docetaxel); Rhone Poulenc Rorer;
Treatment for locally advanced or metastatic breast cancer, Approved May 1996
Teczem (enalapril maleate/diltiazem malate); Hoechst Marion Roussel;
Treatment for hypertension, Approved October 1996
Tiazac (diltiazem hydrochloride); Forest Laboratories;
Treatment for hypertension, Approved February 1996
Vivelle (estradiol transdermal system); Ciba Pharmaceuticals;
Treatment for moderate and severe vasomotor menopausal symptoms, Approved March 1996
Zoladex (10.8 mg goserelin acetate implant); AstraZeneca;
Treatment for advanced prostate cancer, Approved January 1996
Family Medicine
Accolate; AstraZeneca;
Treatment for asthma, Approved October 1996
Adderall (mixed salts of a single-entity amphetamine); Richwood Pharmaceutical;
Treatment for attention-deficit/hyperactivity disorder, Supplemental NDA Approved February 1996
Alphagan (brimonidine); Allergan;
Treatment for open-angle glaucoma and ocular hypertension, Approved September 1996
Anexsia; Mallinckrodt Group;
Treatment for chronic pain, Approved August 1996
Apthasol (Amlexanox); Access Pharmaceuticals;
Treatment for canker sores, Approved May 1996
Aredia (pamidronate disodium for injection); Chiron;
Treatment for osteolytic bone metastases of breast cancer, Approved August 1996
ARICEPT (donepezil hydrochloride); Eisai;
Treatment for Alzheimer's Disease, Approved December 1996
Arimidex (anastrozole); AstraZeneca;
Treatment for advanced breast cancer in postmenopausal women, Approved January 1996
Atrovent (ipratropium bromide); Boehringer Ingelheim;
Treatment for runny nose due to allergies and the common cold, Approved January 1996
Augmentin (amoxicillin/clavulanate); SmithKline Beecham;
Treatment for infections involving drug-resistant bacteria, Approved February 1996
Axid AR (nizatidine; Whitehall-Robins Healthcare;
Over-the-counter anti-ulcer treatment, Approved May 1996
Azmacort (triamcinolone acetonide) Inhalation Aerosol; Rhone Poulenc Rorer;
Treatment for asthma, Approved November 1996
Azulfidine EN-tabs Tablets (sulfasalazine delayed release tablets, USP); Pharmacia & Upjohn;
Treatment for rheumatoid arthritis, Approved October 1996
Campostar; Pharmacia & Upjohn;
Treatment for metastatic colorectal cancer, Approved June 1996
Carrington patch; Carrington Laboratories;
Treatment for canker sores, Approved May 1996
CEA-Scan; Immunomedics;
Diagnostic imaging product for colorectal cancer, Approved April 1996
Children's Advil (pediatric ibuprofen); Whitehall-Robins Healthcare;
Treatment of fever and minor aches and pains, Approved July 1996
Claritin Syrup (loratadine); Schering-Plough;
Treatment for children with seasonal allergies, Approved October 1996
Confide; Johnson & Johnson;
HIV testing and counseling service, Approved May 1996
Crixivan (Indinavir sulfate); Merck;
Treatment for HIV infection, Approved March 1996
DentiPatch (lidocaine transoral delivery system); Noven Pharmaceuticals;
Dental anesthetic patch, Approved May 1996
Depakote (divalproex sodium); Abbott Laboratories;
Treatment for epilepsy, Approved June 1996
Depakote (divalproex sodium); Abbott Laboratories;
Treatment for migraine headaches, Approved March 1996
Differin (adapalene gel) Gel, 0.1%; Galderma Laboratories;
Treatment for acne, Approved June 1996
Elmiron (pentosan polysulfate sodium); IVAX;
Treatment for interstitial cystitis, Approved October 1996
Eulexin (flutamide); Schering-Plough;
Treatment for prostate cancer, Approved June 1996
FemPatch; Parke-Davis;
Treatment for menopausal symptoms, Approved December 1996
Feridex I.V.; Advanced Magnetics;
Contrast agent for magnetic resonance imaging of liver lesions, Approved February 1996
Fertinex (urofollitropin for injection, purified); Serono Laboratories;
Treatment for patients undergoing infertility treatments, Approved September 1996
Gastrocrom Oral Concentrate (cromolyn sodium); Rhone Poulenc Rorer;
Treatment for mastocytosis, Approved April 1996
GastroMARK; Advanced Magnetics;
Contrast agent for magnetic resonance imaging of the gastrointestinal tract, Approved May 1996
Gemzar (gemcitabine HCL); Eli Lilly;
Treatment for pancreatic cancer, Approved May 1996
Glyset (miglitol); Bayer;
Treatment for Type II (non-insulin-dependent) diabetes mellitus, Approved December 1996
Humalog (insulin lispro); Eli Lilly;
Treatment for type I and type II diabetes, Approved June 1996
Hycamtin (topotecan hydrochloride); SmithKline Beecham;
Treatment for metastatic ovarian cancer, Approved May 1996
Kadian; Purepac Pharmaceutical;
Treatment for chronic moderate to severe pain, Approved July 1996
Lamisil (terbinafine hydrochloride) Tablets; Sandoz Pharmaceuticals;
Treatment for nail fungal infections, Approved May 1996
Leukine (sargramostim); Immunex;
Treatment for the replenishment of white blood cells, Approved November 1996
Lithobid (Lithium Carbonate); Solvay Pharmaceuticals;
Treatment for manic depression, Approved January 1996
Lodine (etodolac); Wyeth;
Treatment for rheumatoid arthritis, Approved July 1996
Lupron Depot (leuprolide acetate for depot suspension); Abbott Laboratories;
Treatment for advanced prostate cancer, Approved January 1996
Mavik (trandolapril); Knoll Pharmaceutical;
Treatment for hypertension, Approved May 1996
Monistat 3 (miconazole nitrate); Johnson & Johnson;
Over the counter treatment for vaginal yeast infections, Approved April 1996
Monurol; Forest Laboratories;
Treatment for uncomplicated urinary tract infection, Approved December 1996
Muse; Vivus;
Treatment for impotence, Approved October 1996
Naprelan (naproxen sodium); Elan Pharmaceuticals, Wyeth;
Treatment for osteoarthritis and rheumatoid arthritis, Approved January 1996
Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals;
Treatment for vitamin B-12 deficiency, Approved November 1996
Ocuflox (ofloxacin opthalmic solution) 0.3%; Allergan;
Treatment for corneal ulcers, Approved May 1996
OcuHist; Pfizer;
Over-the-counter antihistamine eye drop, Approved January 1996
Oral Cytovene; Roche;
Treatment for the prevention of cytomegalovirus (CMV), Approved December 1996
OxyContin (oxycodone HCl controlled-release); Purdue Pharma;
Treatment for pain associated with musculoskeletal conditions, Approved May 1996
Paxil (paroxetine hydrochloride); SmithKline Beecham;
Treatment for panic disorder, Approved May 1996
Photodynamic Therapy; Sanofi-aventis;
Photodynamic therapy device for the treatment of esophageal cancer, Approved January, 1996
Pravachol (pravastatin sodium); Bristol-Myers Squibb;
Treatment for heart disease, Approved April 1996
Pravachol (pravastatin sodium); Bristol-Myers Squibb;
Treatment for cholesterol-lowering, Approved July 1996
Prilosec (omeprazole); Astra Merck;
Treatment for gastric ulcers, Approved March 1996
Prilosec (omeprazole); Astra Merck;
Treatment for heartburn, gastroesophageal reflux disease (GERD), Approved December 1996
Prilosec (omeprazole)/Biaxin (clarithromycin) Combination Therapy; Astra Merck, Abbott Laboratories;
Treatment for duodenal ulcers, Approved April 1996
ProAmatine (midodrine); Roberts Pharmaceutical;
Treatment for hypotension, Approved September 1996
Procanbid (procainamide hydrochloride extended-release tablets); Warner-Lambert;
Treatment for ventricular arrhythmias, Approved January 1996
Remeron (Mirtazapine); Organon;
Treatment for depression, Approved June 1996
RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); MedImmune;
Treatment for the prevention of respiratory syncytial virus disease, Approved January 1996
Retavase (reteplase); Boehringer Mannheim Corporation;
Treatment for patients suffering from heart attack, Approved November 1996
Tavist (clemastine fumarate); Sandoz Pharmaceuticals;
Treatment for cold symptoms, Approved November 1996
Taxotere (Docetaxel); Rhone Poulenc Rorer;
Treatment for locally advanced or metastatic breast cancer, Approved May 1996
Teczem (enalapril maleate/diltiazem malate); Hoechst Marion Roussel;
Treatment for hypertension, Approved October 1996
Tegretol (carbamazepine); Ciba Pharmaceuticals;
Treatment for young children with epilepsy, Approved March 1996
Tegretol XR (carbamazepine); Ciba-Geigy;
Anti-epileptic treatment, Approved May 1996
Tiazac (diltiazem hydrochloride); Forest Laboratories;
Treatment for hypertension, Approved February 1996
UltraJect; Mallinckrodt Group;
Treatment for chronic pain, Approved August 1996
Videx (didanosine); Bristol-Myers Squibb;
Treatment of HIV infection, Approved June 1996
Viramune (nevirapine); Boehringer Ingelheim;
Treatment for HIV infection, Approved June 1996
Vistide (cidofovir); Gilead;
Treatment for cytomegalovirus (CMV) retinitis, Approved June 1996
Vitrasert Implant; Chiron;
Drug delivery system for the treatment of cytomegalovirus, Approved March 1996
Vivelle (estradiol transdermal system); Ciba Pharmaceuticals;
Treatment for moderate and severe vasomotor menopausal symptoms, Approved March 1996
Zoladex (10.8 mg goserelin acetate implant); AstraZeneca;
Treatment for advanced prostate cancer, Approved January 1996
Gastroenterology
Axid AR (nizatidine; Whitehall-Robins Healthcare;
Over-the-counter anti-ulcer treatment, Approved May 1996
Cipro (ciprofloxacin) I.V. and Cipro (ciprofloxacin HCI) tablets; Bayer;
Treatment for complicated intra-abdominal infections, Approved December 1996
GastroMARK; Advanced Magnetics;
Contrast agent for magnetic resonance imaging of the gastrointestinal tract, Approved May 1996
Merrem I.V. (meropenem); AstraZeneca;
Treatment for intra-abdominal infections and bacterial meningitis, Approved June 1996
Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals;
Treatment for vitamin B-12 deficiency, Approved November 1996
Prilosec (omeprazole); Astra Merck;
Treatment for heartburn, gastroesophageal reflux disease (GERD), Approved December 1996
Prilosec (omeprazole); Astra Merck;
Treatment for gastric ulcers, Approved March 1996
Prilosec (omeprazole)/Biaxin (clarithromycin) Combination Therapy; Astra Merck, Abbott Laboratories;
Treatment for duodenal ulcers, Approved April 1996
Seprafilm; Genzyme;
Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery, Approved August 1996
Visipaque (iodixanol); Nycomed;
Diagnostic contrast agent, Approved April 1996
Genetic Disease
AlphaNine SD Coagulation Factor IX (Human); Alpha Therapeutic Corporation;
Treatment for the prevention and control of bleeding in subjects with hemophilia, Approved July 1996
Depakote (divalproex sodium); Abbott Laboratories;
Treatment for epilepsy, Approved June 1996
Pulmozyme (dornase alfa); Genentech;
Treatment for cystic fibrosis patients with advanced disease, Approved December 1996
Saizen; Ares-Serono;
Treatment for growth hormone deficiency and Turner Syndrome, Approved May 1996
Tegretol (carbamazepine); Ciba Pharmaceuticals;
Treatment for young children with epilepsy, Approved March 1996
Tegretol XR (carbamazepine); Ciba-Geigy;
Anti-epileptic treatment, Approved May 1996
Hematology
AlphaNine SD Coagulation Factor IX (Human); Alpha Therapeutic Corporation;
Treatment for the prevention and control of bleeding in subjects with hemophilia, Approved July 1996
Gastrocrom Oral Concentrate (cromolyn sodium); Rhone Poulenc Rorer;
Treatment for mastocytosis, Approved April 1996
Leukine (sargramostim); Immunex;
Treatment for the replenishment of white blood cells, Approved November 1996
Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals;
Treatment for vitamin B-12 deficiency, Approved November 1996
Pravachol (pravastatin sodium); Bristol-Myers Squibb;
Treatment for cholesterol-lowering, Approved July 1996
Visipaque (iodixanol); Nycomed;
Diagnostic contrast agent, Approved April 1996
Hepatology (Liver, Pancreatic, Gall Bladder)
Feridex I.V.; Advanced Magnetics;
Contrast agent for magnetic resonance imaging of liver lesions, Approved February 1996
Havrix; SmithKline Beecham;
Treatment for hepatitis A, Approved March 1996
Prilosec (omeprazole); Astra Merck;
Treatment for gastric ulcers, Approved March 1996
Pulmozyme (dornase alfa); Genentech;
Treatment for cystic fibrosis patients with advanced disease, Approved December 1996
Zithromax (azithromycin); Pfizer;
Treatment for Mycobacterium avium complex (MAC) in subjects with advanced HIV infection, Approved June 1996
Immunology
Albenza (albendazole); SmithKline Beecham;
Treatment for parasitic infections caused by worms, Approved June 1996
Apthasol (Amlexanox); Access Pharmaceuticals;
Treatment for canker sores, Approved May 1996
Carrington patch; Carrington Laboratories;
Treatment for canker sores, Approved May 1996
Confide; Johnson & Johnson;
HIV testing and counseling service, Approved May 1996
Crixivan (Indinavir sulfate); Merck;
Treatment for HIV infection, Approved March 1996
Gastrocrom Oral Concentrate (cromolyn sodium); Rhone Poulenc Rorer;
Treatment for mastocytosis, Approved April 1996
Havrix; SmithKline Beecham;
Treatment for hepatitis A, Approved March 1996
Lamisil (terbinafine hydrochloride) Tablets; Sandoz Pharmaceuticals;
Treatment for nail fungal infections, Approved May 1996
Leukine (sargramostim); Immunex;
Treatment for the replenishment of white blood cells, Approved November 1996
Oral Cytovene; Roche;
Treatment for the prevention of cytomegalovirus (CMV), Approved December 1996
RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); MedImmune;
Treatment for the prevention of respiratory syncytial virus disease, Approved January 1996
Videx (didanosine); Bristol-Myers Squibb;
Treatment of HIV infection, Approved June 1996
Viramune (nevirapine); Boehringer Ingelheim;
Treatment for HIV infection, Approved June 1996
Vistide (cidofovir); Gilead;
Treatment for cytomegalovirus (CMV) retinitis, Approved June 1996
Vitrasert Implant; Chiron;
Drug delivery system for the treatment of cytomegalovirus, Approved March 1996
Zithromax (azithromycin); Pfizer;
Treatment for Mycobacterium avium complex (MAC) in subjects with advanced HIV infection, Approved June 1996
Infections and Infectious Diseases
AK-Con-A (naphazoline ophthalmic); Akorn;
Over-the-counter combination vasoconstrictor/antihistamine product for opthalmic use, Approved January 1996
Allegra (fexofenadine hydrochloride); Hoechst Marion Roussel;
Treatment for seasonal allergy symptoms, Approved July 1996
Astelin nasal spray; Wallace Laboratories;
Treatment for seasonal allergic rhinitis, Approved November 1996
Atrovent (ipratropium bromide); Boehringer Ingelheim;
Treatment for runny nose due to allergies and the common cold, Approved January 1996
Augmentin (amoxicillin/clavulanate); SmithKline Beecham;
Treatment for infections involving drug-resistant bacteria, Approved February 1996
Children's Advil (pediatric ibuprofen); Whitehall-Robins Healthcare;
Treatment of fever and minor aches and pains, Approved July 1996
Confide; Johnson & Johnson;
HIV testing and counseling service, Approved May 1996
Crixivan (Indinavir sulfate); Merck;
Treatment for HIV infection, Approved March 1996
Elmiron (pentosan polysulfate sodium); IVAX;
Treatment for interstitial cystitis, Approved October 1996
Havrix; SmithKline Beecham;
Treatment for hepatitis A, Approved March 1996
IvyBlock; EnviroDerm Pharmaceuticals;
Treatment for poison ivy, poison oak, and poison sumac, Approved September 1996
Lamisil (terbinafine hydrochloride) Tablets; Sandoz Pharmaceuticals;
Treatment for nail fungal infections, Approved May 1996
Leukine (sargramostim); Immunex;
Treatment for the replenishment of white blood cells, Approved November 1996
Merrem I.V. (meropenem); AstraZeneca;
Treatment for intra-abdominal infections and bacterial meningitis, Approved June 1996
Nasacort AQ (triamcinolone acetonide) Nasal Spray; Rhone Poulenc Rorer;
Treatment for allergic rhinitis, Approved May 1996
OcuHist; Pfizer;
Over-the-counter antihistamine eye drop, Approved January 1996
RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); MedImmune;
Treatment for the prevention of respiratory syncytial virus disease, Approved January 1996
Tavist (clemastine fumarate); Sandoz Pharmaceuticals;
Treatment for cold symptoms, Approved November 1996
Vancenase AQ 84 mcg Double Strength; Schering-Plough;
Treatment for allergic and non-allergic rhinitis, Approved June 1996
Videx (didanosine); Bristol-Myers Squibb;
Treatment of HIV infection, Approved June 1996
Viramune (nevirapine); Boehringer Ingelheim;
Treatment for HIV infection, Approved June 1996
Zithromax (azithromycin); Pfizer;
Treatment for Mycobacterium avium complex (MAC) in subjects with advanced HIV infection, Approved June 1996
Musculoskeletal
Kadian; Purepac Pharmaceutical;
Treatment for chronic moderate to severe pain, Approved July 1996
Naprelan (naproxen sodium); Elan Pharmaceuticals, Wyeth;
Treatment for osteoarthritis and rheumatoid arthritis, Approved January 1996
OxyContin (oxycodone HCl controlled-release); Purdue Pharma;
Treatment for pain associated with musculoskeletal conditions, Approved May 1996
Saizen; Ares-Serono;
Treatment for growth hormone deficiency and Turner Syndrome, Approved May 1996
Seprafilm; Genzyme;
Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery, Approved August 1996
Zanaflex (tizanidine hydrochloride); Elan Pharmaceuticals;
Treatment for muscle spasticity, Approved December 1996
Nephrology
Cipro (ciprofloxacin HCl); Bayer;
Treatment for cystitis, Approved April 1996
Elmiron (pentosan polysulfate sodium); IVAX;
Treatment for interstitial cystitis, Approved October 1996
Eulexin (flutamide); Schering-Plough;
Treatment for prostate cancer, Approved June 1996
Gemzar (gemcitabine HCL); Eli Lilly;
Treatment for pancreatic cancer, Approved May 1996
Lupron Depot (leuprolide acetate for depot suspension); Abbott Laboratories;
Treatment for advanced prostate cancer, Approved January 1996
Monurol; Forest Laboratories;
Treatment for uncomplicated urinary tract infection, Approved December 1996
Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals;
Treatment for vitamin B-12 deficiency, Approved November 1996
Seprafilm; Genzyme;
Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery, Approved August 1996
Visipaque (iodixanol); Nycomed;
Diagnostic contrast agent, Approved April 1996
Zoladex (10.8 mg goserelin acetate implant); AstraZeneca;
Treatment for advanced prostate cancer, Approved January 1996
Neurology
Anexsia; Mallinckrodt Group;
Treatment for chronic pain, Approved August 1996
ARICEPT (donepezil hydrochloride); Eisai;
Treatment for Alzheimer's Disease, Approved December 1996
Depakote (divalproex sodium); Abbott Laboratories;
Treatment for epilepsy, Approved June 1996
Depakote (divalproex sodium); Abbott Laboratories;
Treatment for migraine headaches, Approved March 1996
Iontocaine; Iomed;
Needle-free anesthetic, Approved May 1996
Kadian; Purepac Pharmaceutical;
Treatment for chronic moderate to severe pain, Approved July 1996
Merrem I.V. (meropenem); AstraZeneca;
Treatment for intra-abdominal infections and bacterial meningitis, Approved June 1996
Redux (dexfenfluramine hydrochloride); Wyeth;
Treatment for obesity, Approved May 1996
Tegretol (carbamazepine); Ciba Pharmaceuticals;
Treatment for young children with epilepsy, Approved March 1996
Tegretol XR (carbamazepine); Ciba-Geigy;
Anti-epileptic treatment, Approved May 1996
UltraJect; Mallinckrodt Group;
Treatment for chronic pain, Approved August 1996
Visipaque (iodixanol); Nycomed;
Diagnostic contrast agent, Approved April 1996
Zanaflex (tizanidine hydrochloride); Elan Pharmaceuticals;
Treatment for muscle spasticity, Approved December 1996
Nutrition and Weight Loss
Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals;
Treatment for vitamin B-12 deficiency, Approved November 1996
Redux (dexfenfluramine hydrochloride); Wyeth;
Treatment for obesity, Approved May 1996
Obstetrics/Gynecology (Women’s Health)
Aredia (pamidronate disodium for injection); Chiron;
Treatment for osteolytic bone metastases of breast cancer, Approved August 1996
Arimidex (anastrozole); AstraZeneca;
Treatment for advanced breast cancer in postmenopausal women, Approved January 1996
Estrostep (norethindrone acetate and ethinyl estradiol); Parke-Davis;
Treatment for birth control, Approved October 1996
FemPatch; Parke-Davis;
Treatment for menopausal symptoms, Approved December 1996
Fertinex (urofollitropin for injection, purified); Serono Laboratories;
Treatment for patients undergoing infertility treatments, Approved September 1996
Hycamtin (topotecan hydrochloride); SmithKline Beecham;
Treatment for metastatic ovarian cancer, Approved May 1996
Monistat 3 (miconazole nitrate); Johnson & Johnson;
Over the counter treatment for vaginal yeast infections, Approved April 1996
Seprafilm; Genzyme;
Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery, Approved August 1996
Taxotere (Docetaxel); Rhone Poulenc Rorer;
Treatment for locally advanced or metastatic breast cancer, Approved May 1996
Vivelle (estradiol transdermal system); Ciba Pharmaceuticals;
Treatment for moderate and severe vasomotor menopausal symptoms, Approved March 1996
Oncology
Anexsia; Mallinckrodt Group;
Treatment for chronic pain, Approved August 1996
Aredia (pamidronate disodium for injection); Chiron;
Treatment for osteolytic bone metastases of breast cancer, Approved August 1996
Arimidex (anastrozole); AstraZeneca;
Treatment for advanced breast cancer in postmenopausal women, Approved January 1996
Campostar; Pharmacia & Upjohn;
Treatment for metastatic colorectal cancer, Approved June 1996
CEA-Scan; Immunomedics;
Diagnostic imaging product for colorectal cancer, Approved April 1996
Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection); Orphan Medical;
Treatment of meningeal leukemia or lymphocytic lymphoma, Approved October 1996
Eulexin (flutamide); Schering-Plough;
Treatment for prostate cancer, Approved June 1996
Feridex I.V.; Advanced Magnetics;
Contrast agent for magnetic resonance imaging of liver lesions, Approved February 1996
GastroMARK; Advanced Magnetics;
Contrast agent for magnetic resonance imaging of the gastrointestinal tract, Approved May 1996
Gemzar (gemcitabine HCL); Eli Lilly;
Treatment for pancreatic cancer, Approved May 1996
Hycamtin (topotecan hydrochloride); SmithKline Beecham;
Treatment for metastatic ovarian cancer, Approved May 1996
Kadian; Purepac Pharmaceutical;
Treatment for chronic moderate to severe pain, Approved July 1996
Leukine (sargramostim); Immunex;
Treatment for the replenishment of white blood cells, Approved November 1996
Lupron Depot (leuprolide acetate for depot suspension); Abbott Laboratories;
Treatment for advanced prostate cancer, Approved January 1996
Photodynamic Therapy; Sanofi-aventis;
Photodynamic therapy device for the treatment of esophageal cancer, Approved January, 1996
Taxotere (Docetaxel); Rhone Poulenc Rorer;
Treatment for locally advanced or metastatic breast cancer, Approved May 1996
UltraJect; Mallinckrodt Group;
Treatment for chronic pain, Approved August 1996
Visipaque (iodixanol); Nycomed;
Diagnostic contrast agent, Approved April 1996
Zoladex (10.8 mg goserelin acetate implant); AstraZeneca;
Treatment for advanced prostate cancer, Approved January 1996
Ophthalmology
AK-Con-A (naphazoline ophthalmic); Akorn;
Over-the-counter combination vasoconstrictor/antihistamine product for opthalmic use, Approved January 1996
Alphagan (brimonidine); Allergan;
Treatment for open-angle glaucoma and ocular hypertension, Approved September 1996
Ocuflox (ofloxacin opthalmic solution) 0.3%; Allergan;
Treatment for corneal ulcers, Approved May 1996
OcuHist; Pfizer;
Over-the-counter antihistamine eye drop, Approved January 1996
Vistide (cidofovir); Gilead;
Treatment for cytomegalovirus (CMV) retinitis, Approved June 1996
Vitrasert Implant; Chiron;
Drug delivery system for the treatment of cytomegalovirus, Approved March 1996
Otolaryngology (Ear, Nose, Throat)
Bactroban Nasal 2% (mupirocin calcium ointment); SmithKline Beecham;
Treatment for nasal bacteria, Approved April 1996
Pediatrics/Neonatology
Adderall (mixed salts of a single-entity amphetamine); Richwood Pharmaceutical;
Treatment for attention-deficit/hyperactivity disorder, Supplemental NDA Approved February 1996
Children's Advil (pediatric ibuprofen); Whitehall-Robins Healthcare;
Treatment of fever and minor aches and pains, Approved July 1996
Claritin Syrup (loratadine); Schering-Plough;
Treatment for children with seasonal allergies, Approved October 1996
Havrix; SmithKline Beecham;
Treatment for hepatitis A, Approved March 1996
Merrem I.V. (meropenem); AstraZeneca;
Treatment for intra-abdominal infections and bacterial meningitis, Approved June 1996
RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); MedImmune;
Treatment for the prevention of respiratory syncytial virus disease, Approved January 1996
Tegretol (carbamazepine); Ciba Pharmaceuticals;
Treatment for young children with epilepsy, Approved March 1996
Tripedia (Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed); Connaught Laboratories;
Treatment for whooping cough, Approved August 1996
Pharmacology/Toxicology
Iontocaine; Iomed;
Needle-free anesthetic, Approved May 1996
Lamisil (terbinafine hydrochloride) Tablets; Sandoz Pharmaceuticals;
Treatment for nail fungal infections, Approved May 1996
Nascobal Gel (Cyanocobalamin, USP); Questcor Pharmaceuticals;
Treatment for vitamin B-12 deficiency, Approved November 1996
Psychiatry/Psychology
Adderall (mixed salts of a single-entity amphetamine); Richwood Pharmaceutical;
Treatment for attention-deficit/hyperactivity disorder, Supplemental NDA Approved February 1996
ARICEPT (donepezil hydrochloride); Eisai;
Treatment for Alzheimer's Disease, Approved December 1996
Depakote (divalproex sodium); Abbott Laboratories;
Treatment for migraine headaches, Approved March 1996
Lithobid (Lithium Carbonate); Solvay Pharmaceuticals;
Treatment for manic depression, Approved January 1996
NicoDerm CQ; SmithKline Beecham, Hoechst Marion Roussel, Alza;
Treatment for smoking cessation, Approved August 1996
Nicorette (nicotine polacrilex); SmithKline Beecham;
Over-the-counter aid in smoking cessation, Approved February 1996
Nicotrol nasal spray; Pharmacia & Upjohn;
Treatment for nicotine addiction, Approved March 1996
Nicotrol transdermal patch; McNeil Consumer Products;
Treatment for smoking cessation, Approved July 1996
Paxil (paroxetine hydrochloride); SmithKline Beecham;
Treatment for panic disorder, Approved May 1996
Redux (dexfenfluramine hydrochloride); Wyeth;
Treatment for obesity, Approved May 1996
Remeron (Mirtazapine); Organon;
Treatment for depression, Approved June 1996
Risperdal Oral Formulation; Janssen Pharmaceuticals;
Treatment for schizophrenia, Approved July 1996
Zyprexa; Eli Lilly;
Treatment of the symptoms of psychotic disorders, Approved September 1996
Pulmonary/Respiratory Diseases
Accolate; AstraZeneca;
Treatment for asthma, Approved October 1996
Allegra (fexofenadine hydrochloride); Hoechst Marion Roussel;
Treatment for seasonal allergy symptoms, Approved July 1996
Astelin nasal spray; Wallace Laboratories;
Treatment for seasonal allergic rhinitis, Approved November 1996
Atrovent (ipratropium bromide); Boehringer Ingelheim;
Treatment for runny nose due to allergies and the common cold, Approved January 1996
Augmentin (amoxicillin/clavulanate); SmithKline Beecham;
Treatment for infections involving drug-resistant bacteria, Approved February 1996
Azmacort (triamcinolone acetonide) Inhalation Aerosol; Rhone Poulenc Rorer;
Treatment for asthma, Approved November 1996
Breathe Right; CNS;
Treatment for breathing difficulties due to deviated nasal septum, Approved June 1996
Claritin Syrup (loratadine); Schering-Plough;
Treatment for children with seasonal allergies, Approved October 1996
Claritin-D 24 Hour Extended Release Tablets (10 mg loratadine, 240 mg pseudoephedrine sulfate); Schering-Plough;
Treatment for nasal congestion, Approved August 1996
Covera-HS (verapamil); G.D. Searle, Alza;
Treatment for hypertension and angina, Approved January 1996
Nasacort AQ (triamcinolone acetonide) Nasal Spray; Rhone Poulenc Rorer;
Treatment for allergic rhinitis, Approved May 1996
OcuHist; Pfizer;
Over-the-counter antihistamine eye drop, Approved January 1996
Pulmozyme (dornase alfa); Genentech;
Treatment for cystic fibrosis patients with advanced disease, Approved December 1996
RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous); MedImmune;
Treatment for the prevention of respiratory syncytial virus disease, Approved January 1996
Tavist (clemastine fumarate); Sandoz Pharmaceuticals;
Treatment for cold symptoms, Approved November 1996
Tripedia (Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed); Connaught Laboratories;
Treatment for whooping cough, Approved August 1996
Vancenase AQ 84 mcg Double Strength; Schering-Plough;
Treatment for allergic and non-allergic rhinitis, Approved June 1996
Visipaque (iodixanol); Nycomed;
Diagnostic contrast agent, Approved April 1996
Zosyn (sterile piperacillin sodium/tazobactam sodium); Wyeth;
Treatment for hospital-acquired pneumonia, Approved May 1996
Rheumatology
Azulfidine EN-tabs Tablets (sulfasalazine delayed release tablets, USP); Pharmacia & Upjohn;
Treatment for rheumatoid arthritis, Approved October 1996
Lodine (etodolac); Wyeth;
Treatment for rheumatoid arthritis, Approved July 1996
Naprelan (naproxen sodium); Elan Pharmaceuticals, Wyeth;
Treatment for osteoarthritis and rheumatoid arthritis, Approved January 1996
Trauma (Emergency, Injury, Surgery)
Iamin; ProCyte;
Gel wound dressing, Approved February 1996
OsmoCyte Pillow Wound Dressing; ProCyte;
Treatment for chronic and acute wounds, Approved December 1996
Urology
Eulexin (flutamide); Schering-Plough;
Treatment for prostate cancer, Approved June 1996
Fertinex (urofollitropin for injection, purified); Serono Laboratories;
Treatment for patients undergoing infertility treatments, Approved September 1996
Lupron Depot (leuprolide acetate for depot suspension); Abbott Laboratories;
Treatment for advanced prostate cancer, Approved January 1996
Monurol; Forest Laboratories;
Treatment for uncomplicated urinary tract infection, Approved December 1996
Muse; Vivus;
Treatment for impotence, Approved October 1996
Zoladex (10.8 mg goserelin acetate implant); AstraZeneca;
Treatment for advanced prostate cancer, Approved January 1996
Vaccines
Augmentin (amoxicillin/clavulanate); SmithKline Beecham;
Treatment for infections involving drug-resistant bacteria, Approved February 1996
Havrix; SmithKline Beecham;
Treatment for hepatitis A, Approved March 1996
Merrem I.V. (meropenem); AstraZeneca;
Treatment for intra-abdominal infections and bacterial meningitis, Approved June 1996
Tripedia (Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed); Connaught Laboratories;
Treatment for whooping cough, Approved August 1996
Zosyn (sterile piperacillin sodium/tazobactam sodium); Wyeth;
Treatment for hospital-acquired pneumonia, Approved May 1996
