Description of Medical Areas
About the FDA Approved Listings
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Drugs Approved by the FDA (1997)
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The following drugs have been approved this year by
the Food and Drug Administration.
Cardiology/Vascular Diseases
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Corlopam; Treatment for severe high blood pressure; Neurex; Approved September 1997 Diovan; Oral capsules and tablets for the treatment of hypertension; Novartis; Approved January 1997 (capsules); July 2001 (tablets) Diovan (valsartan); Treatment for hypertension; Ciba Pharmaceuticals; Approved January 1997 DynaCirc CR; Treatment for hypertension; Novartis; Approved February 1997 EDEX; Treatment for erectile dysfunction; Schwarz Pharma; Approved June 1997 Lescol; Treatment for coronary atherosclerosis; Novartis; Approved September 1997 Normiflo; Treatment for deep venous thrombosis; Wyeth-Ayerst Laboratories; Approved May 1997 Pentoxifylline; Generic equivalent of Trental; Faulding, Mylan Laboratories; Approved July 1997 Pindolol; Generic equivalent of Visken; Teva Pharmaceutical; Approved April 1997 PLAVIX; Treatment for cardiac atherosclerotic events; Sanofi, Bristol-Myers Squibb; Approved November 1997 Posicor; Treatment for hypertension and chronic stable angina pectoris; Roche; Approved June 1997 ReoPro; Treatment for cardiac ischemic complications; Centocor; Approved November 1997 Teveten; Treatment for hypertension; SmithKline Beecham; Approved December 1997 Verapamil; Generic equivalent of Knoll's Isoptin SR and Searle's Calan SR; IVAX; Approved December 1997 Zocor; Treatment for high cholesterol; Merck; Approved November 1997
Dental/Maxillofacial Surgery
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Aphthasol; Treatment for canker sores; Block Drug Company; Approved December 1997
Dermatology/Plastic Surgery
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Avita; Treatment for acne; Penederm; Approved January 1997 Bactroban Cream; Treatment for secondarily infected traumatic skin lesions; SmithKline Beecham; Approved December 1997 Dermagraft-TC; Treatment for partial-thickness and severe burns; Advanced Tissue Sciences; Approved October 1997 Mentax; Treatment for tinea corporis (ringworm) and tinea cruris (groin fungus); Penederm; Approved January 1997 Mentax; Treatment for athlete's foot; Penederm; Approved December 1997 Omnicef; Treatment against various bacterias; Warner-Lambert; Approved December 1997 Propecia; Treatment for male baldness; Merck; Approved December 1997
Corlopam; Treatment for severe high blood pressure; Neurex; Approved September 1997 Diovan; Oral capsules and tablets for the treatment of hypertension; Novartis; Approved January 1997 (capsules); July 2001 (tablets) Diovan (valsartan); Treatment for hypertension; Ciba Pharmaceuticals; Approved January 1997 DynaCirc CR; Treatment for hypertension; Novartis; Approved February 1997 Estradiol; Generic equivalent of Estrace tablets; Duramed Pharmaceuticals; Approved December 1997 Estrostep; Treatment for oral contraception; Warner-Lambert; Approved March 1997 Evista; Treatment for the prevention of osteoporosis; Eli Lilly; Approved December 1997 Femara; Treatment for breast cancer; Novartis; Approved July 1997 Glipizide Tablets; Treatment for diabetes; Duramed Pharmaceuticals; Approved September 1997 Glyburide Tablets; Treatment for blood-glucose lowering; Roche; Approved December 1997 Glyburide Tablets; Generic version of Glynase PresTab; Mova Pharmaceutical; Approved December 1997 Lescol; Treatment for coronary atherosclerosis; Novartis; Approved September 1997 MERIDIA; Treatment for obesity; Knoll Pharmaceutical; Approved November 1997 Nutropin; Treatment for growth hormone deficiency; Genentech; Approved December 1997 Pindolol; Generic equivalent of Visken; Teva Pharmaceutical; Approved April 1997 PLAVIX; Treatment for cardiac atherosclerotic events; Sanofi, Bristol-Myers Squibb; Approved November 1997 Posicor; Treatment for hypertension and chronic stable angina pectoris; Roche; Approved June 1997 Prandin; Treatment for Type II diabetes; Novo Nordisk; Approved December 1997 Prograf; Treatment for the prevention of kidney transplant rejection; Fujisawa Healthcare; Approved April 1997 Teveten; Treatment for hypertension; SmithKline Beecham; Approved December 1997 Trazadone 150mg; Generic equivalent of Desyrel 7; Teva Pharmaceutical; Approved May 1997 Trivora-21 and Trivora-28; Generic equivalents of levonorgestrel and ethinyl estradiol; Watson Pharmaceuticals; Approved December 1997 Verapamil; Generic equivalent of Knoll's Isoptin SR and Searle's Calan SR; IVAX; Approved December 1997 Zenapax; Treatment to prevent rejection of kidney transplants; Roche; Approved December 1997 Zerit (stavudine, d4T); Treatment for infants and children infected with HIV; Bristol-Myers Squibb; Approved January 1997
Prevpac; Treatment for duodenal ulcers; TAP Pharmaceuticals; Approved December 1997 Prochloroperazine; Generic equivalent of Compazine; Duramed Pharmaceuticals; Approved May 1997 Ranitidine Capsules; Generic equivalent of Zantac GELdose; Geneva Pharmaceuticals; Approved October 1997 Urso; Treatment for primary biliary cirrhosis; Axcan Schwarz; Approved December 1997
Glyburide Tablets; Treatment for blood-glucose lowering; Roche; Approved December 1997 Glyburide Tablets; Generic version of Glynase PresTab; Mova Pharmaceutical; Approved December 1997 Neumega; Treatment for thrombocytopenia; Genetics Institute; Approved November 1997 Rituxan; Treatment for non-hodgkin's lymphoma; Idec Pharmaceuticals, Genentech; Approved November 1997
Immunology/Infectious Diseases
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Acyclovir Capsules; Generic equivalent of Zovirax; Teva Pharmaceutical; Approved April 1997 Aldara (imiquimod); Treatment for external genital and perianal warts; 3M Pharmaceuticals; Approved March 1997 Aphthasol; Treatment for canker sores; Block Drug Company; Approved December 1997 Combivir; Treatment for AIDS and HIV Infection; GlaxoWellcome; Approved September 1997 Flagyl ER; Treatment for bacterial vaginosis; Searle; Approved December 1997 Flonase Nasal Spray; Treatment for seasonal and perennial allergic rhinitis; GlaxoWellcome; Approved November 1997 Fortovase; Treatment for HIV infection; Roche; Approved November 1997 Norvir (ritonavir); Treatment for HIV infection; Abbott Laboratories; Approved March 1996/March 1997 Taxol; Treatment for AIDS-related Kaposi's Sarcoma; Bristol-Myers Squibb; Approved August 1997 Trovan; Treatment for bacterial infections; Pfizer; Approved December 1997 Zerit (stavudine, d4T); Treatment for infants and children infected with HIV; Bristol-Myers Squibb; Approved January 1997
Arthrotec; Treatment for arthritis; Searle; Approved December 1997 Evista; Treatment for the prevention of osteoporosis; Eli Lilly; Approved December 1997 Ketoprofen; Generic equivalent or Oruvail; Schein Pharmaceutical; Approved December 1997 Tolmetin Sodium; Treatment for arthritis; Teva Pharmaceutical; Approved March 1997
EDEX; Treatment for erectile dysfunction; Schwarz Pharma; Approved June 1997 FLOMAX; Treatment for benign prostatic hypertrophy (BPH); Boehringer Ingelheim; Approved October 1997 Prograf; Treatment for the prevention of kidney transplant rejection; Fujisawa Healthcare; Approved April 1997 Zenapax; Treatment to prevent rejection of kidney transplants; Roche; Approved December 1997
Bromfenac; Management of acute pain; Duract, Wyeth-Ayerst Laboratories; Approved July 1997 Carbatrol; Treatment for epileptic seizures and trigeminal neuralgia; Elan; Approved September 1997 Copaxone; Treatment for relapsing-remitting multiple sclerosis; Teva Pharmaceutical; Approved January 1997 Migranal; Treatment for migraine headaches; Novartis; Approved December 1997 Mirapex; Treatment for Parkinson’s Disease; Pharmacia & Upjohn, Boehringer Ingelheim; Approved June 1997 Pramipexole; Treatment for Parkinson's Disease; Pharmacia & Upjohn; Approved July 1997 Selegiline tablets; Generic equivalent of Eldepryl tablets; Teva Pharmaceutical; Approved January 1997 Topamax (topiramate); Treatment for partial onset seizures; Ortho-McNeil Pharmaceutical; Approved January 1997 VERSED (midazolam HCI); Treatment for sedating children who must undergo painful surgery; Roche; Approved March 1997 ZOMIG; Treatment for migraine; Zeneca Pharmaceuticals; Approved November 1997
Estradiol; Generic equivalent of Estrace tablets; Duramed Pharmaceuticals; Approved December 1997 Estrostep; Treatment for oral contraception; Warner-Lambert; Approved March 1997 Evista; Treatment for the prevention of osteoporosis; Eli Lilly; Approved December 1997 Femara; Treatment for breast cancer; Novartis; Approved July 1997 FEMSTAT One; Treatment for vaginal yeast infections; Roche; Approved Februrary 1997 Flagyl ER; Treatment for bacterial vaginosis; Searle; Approved December 1997 Miraluma test; Test for breast cancer; DuPont Pharma Radiopharmaceuticals; Approved May 1997 Trivora-21 and Trivora-28; Generic equivalents of levonorgestrel and ethinyl estradiol; Watson Pharmaceuticals; Approved December 1997
Anzemet; Treatment for emesis; Hoechst Marion Roussel; Approved September 1997 Bromfenac; Management of acute pain; Duract, Wyeth-Ayerst Laboratories; Approved July 1997 Femara; Treatment for breast cancer; Novartis; Approved July 1997 Intron A; Treatment for non-Hodgkin's lymphoma; Schering-Plough; Approved December 1997 Kytril; Prevention of nausea and vomiting associated with chemotherapy; SmithKline Beecham; Approved November 1997 Lupron Depot; Treatment for prostate cancer; TAP Pharmaceuticals; Approved July 1997 Miraluma test; Test for breast cancer; DuPont Pharma Radiopharmaceuticals; Approved May 1997 Neumega; Treatment for thrombocytopenia; Genetics Institute; Approved November 1997 Rituxan; Treatment for non-hodgkin's lymphoma; Idec Pharmaceuticals, Genentech; Approved November 1997 Taxol; Treatment for AIDS-related Kaposi's Sarcoma; Bristol-Myers Squibb; Approved August 1997
Acular; Treatment for post-surgical inflammation following cataract extraction; Allergan; Approved November 1997
Floxin otic; Treatment for otitis media; Daiichi Pharmaceutical; Approved December 1997 Omnicef; Treatment against various bacterias; Warner-Lambert; Approved December 1997
Antizol Injection; Treatment for ethylene glycol poisoning; Orphan Medical; Approved December 1997 Flovent Rotadisk; Treatment of asthma in patients four and older; GlaxoWellcome; Approved November 1997 Floxin otic; Treatment for otitis media; Daiichi Pharmaceutical; Approved December 1997 Norvir (ritonavir); Treatment for HIV infection; Abbott Laboratories; Approved March 1996/March 1997 Omnicef; Treatment against various bacterias; Warner-Lambert; Approved December 1997 Tilade; Treatment for asthma; Rhone Poulenc Rorer; Approved April 1997 Timentin; Treatment for septicemia; SmithKline Beecham; Approved December 1997 Tobi; Treatment for cystic fibrosis; PathoGenesis; Approved December 1997 VERSED (midazolam HCI); Treatment for sedating children who must undergo painful surgery; Roche; Approved March 1997 Zerit (stavudine, d4T); Treatment for infants and children infected with HIV; Bristol-Myers Squibb; Approved January 1997 Zoloft; Treatment of panic disorder in children ages 6-17; Pfizer; Approved October 1997
Antizol Injection; Treatment for ethylene glycol poisoning; Orphan Medical; Approved December 1997 Kytril; Prevention of nausea and vomiting associated with chemotherapy; SmithKline Beecham; Approved November 1997 Omnicef; Treatment against various bacterias; Warner-Lambert; Approved December 1997 Trovan; Treatment for bacterial infections; Pfizer; Approved December 1997
LUVOX (fluvoxamine maleate); Treatment for obsessive compulsive disorder (OCD) in children and adolescents; Solvay Pharmaceuticals, Pharmacia & Upjohn; Approved April 1997 Trazadone 150mg; Generic equivalent of Desyrel 7; Teva Pharmaceutical; Approved May 1997 Zoloft; Treatment for panic disorder; Pfizer; Approved July 1997 Zoloft; Treatment of panic disorder in children ages 6-17; Pfizer; Approved October 1997
Pulmonary/Respiratory Diseases
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Ceftin (cefuroxime axetil); Treatment of secondary bacterial infections of acute bronchitis; GlaxoWellcome; Approved September 1997 Cipro; Treatment for acute sinusitis; Bayer; Approved June 1997 Flonase Nasal Spray; Treatment for seasonal and perennial allergic rhinitis; GlaxoWellcome; Approved November 1997 Flovent Rotadisk; Treatment of asthma in patients four and older; GlaxoWellcome; Approved November 1997 Omnicef; Treatment against various bacterias; Warner-Lambert; Approved December 1997 Serevent; Treatment of asthma; GlaxoWellcome; Approved September 1997 Tilade; Treatment for asthma; Rhone Poulenc Rorer; Approved April 1997 Tobi; Treatment for cystic fibrosis; PathoGenesis; Approved December 1997 Zagam (sparfloxacin) tablets; Treatment for community-acquired pneumonia (CAP) and chronic bronchitis; Rhone Poulenc Rorer; Approved January 1997 Zyflo (Zileuton); Treatment for asthma in patients 12 years and older; Abbott Laboratories; Approved January 1997
Arthrotec; Treatment for arthritis; Searle; Approved December 1997 Ketoprofen; Generic equivalent or Oruvail; Schein Pharmaceutical; Approved December 1997 Tolmetin Sodium; Treatment for arthritis; Teva Pharmaceutical; Approved March 1997
Trauma/Emergency Medicine
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