Listing of Newly Approved Drug Therapies (2000)

Description of Medical Areas

About the FDA Approved Listings

Drugs Approved by the FDA (2000)

Approval Year:

2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 | 1995 | All Years

Cardiology/Vascular Diseases
Dental/Maxillofacial Surgery
Dermatology/Plastic Surgery
Endocrinology
Gastroenterology
Hematology
Immunology/Infectious Diseases
Musculoskeletal
Nephrology/Urology
Neurology

Obstetrics/Gynecology
Oncology
Ophthalmology
Otolaryngology
Pediatrics/Neonatology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma/Emergency Medicine

The following drugs have been approved this year by the Food and Drug Administration.

Cardiology/Vascular Diseases

Angiomax (bivalirudin); For patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA); Medicines Company; Approved December 2000
Argatroban Injection; Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.; Texas Biotechnology Corporation, SmithKline Beecham; Approved June 2000
Atacand HCT; For the treatment of hypertension; AstraZeneca; Approved September 2000
Betapace AF Tablet; For treatment of the irregular heartbeats in patients with atrial fibrillation; Berlex Laboratories; Approved February 2000
Diltiazem HCL, Extended-Release Capsules; For the reduction of high blood pressure; Biovail Laboratories; Approved January 2000
Innohep (tinzaparin sodium) injectable; For the treatment of acute symptomatic deep vein thrombosis; Dupont Pharmaceuticals; Approved July 2000
Lescol XL (fluvastatin sodium) tablet, extended release; For the use as an adjunct to diet to reduce elevated total cholesterol; Novartis; Approved October 2000
Micardis (hydrochlorothiazide; telmisartan) Tablet; For the treatment of hypertension; Boehringer Ingelheim; Approved November 2000
Nitrostat (nitroglycerin) Tablets; For the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.; Parke-Davis; Approved May 2000

Dental/Maxillofacial Surgery

No approvals recorded to date in this area.

Dermatology/Plastic Surgery

Benzamycin (erythromycin 3%-benzoyl peroxide 5% topical gel); For the topical treatment of acne vulgaris; Dermik Laboratories; Approved November 2000
Cefazolin and Dextrose USP; Respiratory tract infections; B Braun Medical; Approved July 2000
Chloraprep (chlorhexidine gluconate); For use as a patient preoperative skin preparation; MEDI FLEX HOSP PRODUCTS; Approved July 2000
Clindamycin phosphate topical gel; For once a day treatment of acne vulgaris; Target Research Associates; Approved November 2000
Lamisil (terbinafine hydrochloride) Solution, 1%; For the treatment of athlete's foot, jock itch and ringworm; Novartis; Approved March 2000
Protopic (tacrolimus) ointment; For short-term and intermittent long-term treatment of moderate to severe atopic dermatitis; Fujisawa Healthcare; Approved December 2000
Skin Exposure Reduction Paste Against Chemical Warfare Agents (SERPACWA); To reduce absorption of chemical warfare agents through the skin; U.S. Army Medical Research, Material Command; Approved February 2000

Endocrinology

Activella (Estradiol/Norethindrone Acetate) Tablets; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause; Novo Nordisk; Approved April 2000
AndroGel testosterone gel; For testosterone replacement therapy in males with testosterone deficiency; Unimed Pharmaceuticals; Approved February 2000
Atacand HCT; For the treatment of hypertension; AstraZeneca; Approved September 2000
Cetrotide; For the prevention of premature ovulation in women undergoing controlled ovarian stimulation; Asta Medica; Approved August 2000
Diltiazem HCL, Extended-Release Capsules; For the reduction of high blood pressure; Biovail Laboratories; Approved January 2000
Hectorol (Doxercalciferol) Injection; To reduce iPTH levels in management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis; Bone Care International; Approved April 2000
Lantus (insulin glargine [rDNA origin] injection); For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia; Aventis Pharmaceuticals; Approved April 2000
Lescol XL (fluvastatin sodium) tablet, extended release; For the use as an adjunct to diet to reduce elevated total cholesterol; Novartis; Approved October 2000
Micardis (hydrochlorothiazide; telmisartan) Tablet; For the treatment of hypertension; Boehringer Ingelheim; Approved November 2000
Mirena (levonorgestrel-releasing intrauterine system); Hormone-releasing system for intrauterine contraception; Berlex Laboratories; Approved December 2000
NovoLog (insulin aspart); An insulin analogue for the treatment of diabetes mellitus.; Novo Nordisk; Approved June 2000
Ovidrel (gonadotropin, chorionic human recombinant); For the induction of final follicular maturation and early luteinization in infertile women; Serono Laboratories; Approved September 2000
Trelstar Depot (Injectable Triptorelin Pamoate); For the palliative treatment of advanced prostate cancer; Debio Rechereche Pharmaceutique, Target Research Associates; Approved June 2000
Viadur (leuprolide acetate implant); For pain relief in men with advanced prostate cancer; Alza; Approved March 2000
Vivelle; For the prevention of postmenopausal osteoporosis; Novartis; Approved August 2000

Gastroenterology

Colazal (balsalazide disodium); Mild to moderately active ulcerative colitis; SALIX PHARMACEUTICALS; Approved July 2000
Lotronex (alosetron HCL) Tablets; Indicated for Irritable Bowel Syndrome (IBS) in females with diarrhea-predominant IBS; GlaxoWellcome; Approved February 2000
Pepcid Complete; For use in the relief of heartburn associated with acid indigestion and sour stomach; Merck; Approved October 2000
Protonix (pantoprazole sodium) Delayed-Release Tablets; For treatment of erosive esophagitis; Wyeth-Ayerst Laboratories; Approved February 2000
Visicol Tablet; For cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age and older; Inkine Pharmaceutical; Approved September 2000

Hematology

Argatroban Injection; Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.; Texas Biotechnology Corporation, SmithKline Beecham; Approved June 2000
Innohep (tinzaparin sodium) injectable; For the treatment of acute symptomatic deep vein thrombosis; Dupont Pharmaceuticals; Approved July 2000
Venofer (iron sucrose injection); For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis; Luitpold Pharmaceuticals; Approved November 2000

Immunology/Infectious Diseases

ABREVA (docosanol); Cold sore/fever blister; AVANIR PHARMACEUTICALS; Approved July 2000
Biaxin XL (clarithromycin extended-release tablets); For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis; Abbott Laboratories; Approved March 2000
Cefazolin and Dextrose USP; Respiratory tract infections; B Braun Medical; Approved July 2000
Children's Motrin Cold; For temporary relief of the common cold; McNeil Consumer Products; Approved August 2000
Evoxac; For the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome; SnowBrand Pharmaceuticals; Approved January 2000
Kaletra Capsules and Oral Solution; For the treatment of HIV-1 infection; Abbott Laboratories; Approved September 2000
Lamisil (terbinafine hydrochloride) Solution, 1%; For the treatment of athlete's foot, jock itch and ringworm; Novartis; Approved March 2000
Lotrisone (clotrimazole/betamethasone diproprionate) lotion; For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis; Schering-Plough; Approved December 2000
Malarone (atovaquone; proguanil hydrochloride) Tablet; For the treatment and prevention of Plasmodium falciparum malaria; GlaxoWellcome; Approved July 2000
Rapamune (sirolimus) Tablets; For treatment of kidney rejection; Wyeth-Ayerst Laboratories; Approved August 2000
Rid Mousse; For the treatment of head, pubic (crab), and body lice; Soltec Research; Approved March 2000
Tri-Nasal Spray (triamcinolone acetonide spray); For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older; Muro Pharmaceutical; Approved February 2000
Trivagizole 3 (clotrimazole) Vaginal Cream; For the treatment of vaginal yeast infections; Taro Pharmaceuticals; Approved April 2000
Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet; For the treatment of HIV-1 infection; GlaxoWellcome; Approved November 2000

Musculoskeletal

Activella (Estradiol/Norethindrone Acetate) Tablets; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause; Novo Nordisk; Approved April 2000
Mobic (meloxicam) Tablets; For relief of the signs and symptoms of osteoarthritis; Boehringer Ingelheim; Approved April 2000
Myobloc; Injectable solution for the treatment of abnormal head position and neck pain associated with cervical dystonia; Elan; Approved December 2000

Nephrology/Urology

Cefazolin and Dextrose USP; Respiratory tract infections; B Braun Medical; Approved July 2000
Detrol LA (tolterodine tartrate); For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency; Pharmacia & Upjohn; Approved December 2000
Hectorol (Doxercalciferol) Injection; To reduce iPTH levels in management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis; Bone Care International; Approved April 2000
Rapamune (sirolimus) Tablets; For treatment of kidney rejection; Wyeth-Ayerst Laboratories; Approved August 2000
Renagel (sevelamer hydrochloride) Tablet; For the reduction of serum phosphorus in patients with end-stage renal disease (ESRD); GELTEX PHARMACEUTICALS; Approved July 2000
Trelstar Depot (Injectable Triptorelin Pamoate); For the palliative treatment of advanced prostate cancer; Debio Rechereche Pharmaceutique, Target Research Associates; Approved June 2000
Venofer (iron sucrose injection); For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis; Luitpold Pharmaceuticals; Approved November 2000
Viadur (leuprolide acetate implant); For pain relief in men with advanced prostate cancer; Alza; Approved March 2000

Neurology

Depakote ER (divalproex sodium); For the prophylaxis (prevention) of migraine headaches in adults; Abbott Laboratories; Approved August 2000
Exelon (rivastigmine tartrate); Indicated for the treatment of mild to moderate dementia of the Alzheimer's type; Novartis; Approved April 2000
Myobloc; Injectable solution for the treatment of abnormal head position and neck pain associated with cervical dystonia; Elan; Approved December 2000
Neurontin (gabapentin) Oral Solution; For the treatment of partial seizures in pediatric patients three years of age and older; Parke-Davis; Approved October 2000
Neurontin (gabapentin) oral solution; Treatment of partial seizures in adults with epilepsy; Parke-Davis; Approved March 2000
Novantrone (mitoxantrone hydrochloride); For reducing neurologic disability and/or the frequency of clinical relapses in patients with multiple sclerosis; Immunex; Approved October 2000
Trileptal (oxcarbazepine) Tablets; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults); Novartis; Approved January 2000
Zonegran (zonisamide) Capsules; Adjunctive therapy for treatment of partial seizures in adults with epilepsy; Dainippon Pharmaceutical; Approved March 2000

Obstetrics/Gynecology

Activella (Estradiol/Norethindrone Acetate) Tablets; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause; Novo Nordisk; Approved April 2000
Cetrotide; For the prevention of premature ovulation in women undergoing controlled ovarian stimulation; Asta Medica; Approved August 2000
Mirena (levonorgestrel-releasing intrauterine system); Hormone-releasing system for intrauterine contraception; Berlex Laboratories; Approved December 2000
Ovidrel (gonadotropin, chorionic human recombinant); For the induction of final follicular maturation and early luteinization in infertile women; Serono Laboratories; Approved September 2000
Trivagizole 3 (clotrimazole) Vaginal Cream; For the treatment of vaginal yeast infections; Taro Pharmaceuticals; Approved April 2000
Vivelle; For the prevention of postmenopausal osteoporosis; Novartis; Approved August 2000

Oncology

Mylotarg (gemtuzumab ozogamicin); For the treatment of CD33 positive acute myeloid leukemia (AML); Wyeth Pharmaceuticals; Approved May 2000
Trelstar Depot (Injectable Triptorelin Pamoate); For the palliative treatment of advanced prostate cancer; Debio Rechereche Pharmaceutique, Target Research Associates; Approved June 2000
Trisenox (arsenic trioxide); For the induction of remission and consolidation in patients with acute promyelocytic leukemia (APL); Cell Therapeutics; Approved September 2000
Viadur (leuprolide acetate implant); For pain relief in men with advanced prostate cancer; Alza; Approved March 2000

Ophthalmology

Betaxon; For lowering IOP in patients with chronic open-angle glaucoma or ocular hypertension; Alcon Laboratories; Approved February 2000
Quixin (levofloxacin); For treatment of bacterial conjunctivitis; Santen; Approved August 2000
Rescula (unoprostone isopropyl ophthalmic solution) 0.15%; For the treatment of open-angle glaucoma or ocular hypertension; Ciba Vision; Approved August 2000
Visudyne (verteporfin for injection); For the treatment of wet age-related macular degeneration (wet AMD); QLT; Approved April 2000

Otolaryngology

Depakote ER (divalproex sodium); For the prophylaxis (prevention) of migraine headaches in adults; Abbott Laboratories; Approved August 2000
Protonix (pantoprazole sodium) Delayed-Release Tablets; For treatment of erosive esophagitis; Wyeth-Ayerst Laboratories; Approved February 2000
Tri-Nasal Spray (triamcinolone acetonide spray); For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older; Muro Pharmaceutical; Approved February 2000

Pediatrics/Neonatology

Lantus (insulin glargine [rDNA origin] injection); For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia; Aventis Pharmaceuticals; Approved April 2000
Neurontin (gabapentin) Oral Solution; For the treatment of partial seizures in pediatric patients three years of age and older; Parke-Davis; Approved October 2000
Trileptal (oxcarbazepine) Tablets; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults); Novartis; Approved January 2000

Pharmacology/Toxicology

No approvals recorded to date in this area.

Psychiatry/Psychology

Concerta; For the treatment of Attention Deficit Hyperactivity Disorder; Alza; Approved August 2000

Pulmonary/Respiratory Diseases

Biaxin XL (clarithromycin extended-release tablets); For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis; Abbott Laboratories; Approved March 2000
Cefazolin and Dextrose USP; Respiratory tract infections; B Braun Medical; Approved July 2000
Tri-Nasal Spray (triamcinolone acetonide spray); For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older; Muro Pharmaceutical; Approved February 2000

Rheumatology

Mobic (meloxicam) Tablets; For relief of the signs and symptoms of osteoarthritis; Boehringer Ingelheim; Approved April 2000
Vivelle; For the prevention of postmenopausal osteoporosis; Novartis; Approved August 2000

Trauma/Emergency Medicine

No approvals recorded to date in this area.

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Drug listings last updated: August 29, 2008 at 2:08:00 PM

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