Description of Medical Areas
About the FDA Approved Listings
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Drugs Approved by the FDA (2001)
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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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Diovan; Oral capsules and tablets for the treatment of hypertension; Novartis; Approved January 1997 (capsules); July 2001 (tablets) Natrecor (nesiritide); For the treatment of patients with acutely decompensated congestive heart failure; Scios; Approved August 2001 TriCor (fenofibrate) tablets; For the treatment of primary hypercholesterolemia, mixed lipidemia and hypertriglyceridemia; Abbott Laboratories; Approved September 2001
Dental/Maxillofacial Surgery
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Dermatology/Plastic Surgery
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Elidel; Topical cream for the treatment of atopic dermatitis; Novartis; Approved December 2001 Finevin; Topical cream for the treatment of mild to moderate inflammatory acne vulgaris; Berlex Laboratories; Approved May 2001 Invanz; Once-daily injectable treatment for bacterial infections; Merck; Approved November 2001 Lamisil Solution, 1%; Topical treatment for tinea (pityriasis) versicolor, althete's foot, jock itch, and ringworm; Novartis; Approved March 2001
Campath; Injectable treatment of B-cell chronic lymphocytic leukemia; Berlex Laboratories; Approved May 2001 Diovan; Oral capsules and tablets for the treatment of hypertension; Novartis; Approved January 1997 (capsules); July 2001 (tablets) Femara (letrozole) Tablets; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer; Novartis; Approved January 2001 Genotropin (somatropin); For the treatment of growth failure in children who were born small for gestational age (SGA); Pharmacia; Approved July 2001 Gleevec; Oral therapy for the treatment of chronic myeloid leukemia; Novartis; Approved May 2001 Levoxyl; Oral therapy for the treatment of hypothyroidism and suppression of thyroid-stimulating hormone (TSH); Jones Pharma; Approved May 2001 Natrecor (nesiritide); For the treatment of patients with acutely decompensated congestive heart failure; Scios; Approved August 2001 Novolog Mix 70/30; Subcutaneous injection for the control of hyperglycemia, associated with type 1 and 2 diabetes; Novo Nordisk; Approved November 2001 Remicade (infliximab); For inhibiting the progression of structural damage in patients with rheumatoid arthritis; Centocor; Approved January 2001 Trelstar LA; Intramuscular injection for the treatment of advanced stage prostate cancer; Debiopharm; Approved June 2001
Canasa (mesalamine); For the treatment of active ulcerative proctitis; Axcan Scandipharm; Approved January 2001 Entocort EC (budesonide); Capsules for the treatment of mild-to-moderate, active Crohn's disease; AstraZeneca; Approved October 2001 Nexium (esomeprazole magnesium); For the eradication of Helicobacter pylori, the healing of erosive esophagitis, and the treatment of symptomatic GERD; AstraZeneca; Approved February 2001 Rebetol (ribavirin); For the treatment of chronic hepatitis C; Schering-Plough; Approved July 2001 Twinrix; For the prevention of hepatitis A and B; GlaxoSmithKline; Approved May 2001
Arixtra; Injectable solution for the prevention of deep vein thrombosis; Organon, Sanofi-Synthelabo; Approved December 2001
Immunology/Infectious Diseases
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Cancidas; Intravenous infusion for the treatment of invasive aspergillosis; Merck; Approved January 2001 Rebetol (ribavirin); For the treatment of chronic hepatitis C; Schering-Plough; Approved July 2001 Spectracef; Oral tablets for the treatment of mild to moderate bacterial infections; TAP Pharmaceuticals; Approved August 2001 Twinrix; For the prevention of hepatitis A and B; GlaxoSmithKline; Approved May 2001 Viread; Once-daily oral tablet for the treatment of human immunodeficiency virus (HIV) infection; Gilead Sciences; Approved October 2001
Genotropin (somatropin); For the treatment of growth failure in children who were born small for gestational age (SGA); Pharmacia; Approved July 2001 Kineret; Injectable therapy for the treatment of rheumatoid arthritis; Amgen; Approved November 2001 Supartz; Joint fluid therapy for treatment of osteoarthritis in the knee; Smith & Nephew Orthopaedics; Approved January 2001
dutasteride; For the treatment of symptomatic benign prostatic hyperplasia; GlaxoSmithKline; Approved November 2001 Invanz; Once-daily injectable treatment for bacterial infections; Merck; Approved November 2001 PhosLo; Oral capsules and gelcaps for the control of hyperphosphatemia in end stage renal failure; Braintree Laboratories; Approved April 2001 Trelstar LA; Intramuscular injection for the treatment of advanced stage prostate cancer; Debiopharm; Approved June 2001
Metadate CD; Oral capsules for the treatment of attention deficit hyperactivity disorder; Celltech Pharmaceuticals; Approved April 2001 Zomig-ZMT (zolmitriptan); Orally disintegrating tablet for the treatment of acute migraine in adults; AstraZeneca; Approved February 2001
Bextra; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain; Pharmacia, Pfizer; Approved November 2001 Femara (letrozole) Tablets; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer; Novartis; Approved January 2001 Invanz; Once-daily injectable treatment for bacterial infections; Merck; Approved November 2001 NuvaRing; Monthly vaginal ring for birth control; Organon; Approved October 2001 Ortho Evra; Transdermal patch for contraception; Ortho-McNeil Pharmaceutical; Approved November 2001
Campath; Injectable treatment of B-cell chronic lymphocytic leukemia; Berlex Laboratories; Approved May 2001 Femara (letrozole) Tablets; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer; Novartis; Approved January 2001 Gleevec; Oral therapy for the treatment of chronic myeloid leukemia; Novartis; Approved May 2001 Trelstar LA; Intramuscular injection for the treatment of advanced stage prostate cancer; Debiopharm; Approved June 2001 Xeloda; Oral chemotherapy for the treatment of metastatic colorectal cancer; Roche; Approved May 2001
Adderall XR; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD); Shire Pharmaceuticals; Approved October 2001 Genotropin (somatropin); For the treatment of growth failure in children who were born small for gestational age (SGA); Pharmacia; Approved July 2001 Metadate CD; Oral capsules for the treatment of attention deficit hyperactivity disorder; Celltech Pharmaceuticals; Approved April 2001 NasalCrom Nasal Spray; Over-the-counter nasal spray for treatment of all nasal allergy symptoms; Pharmacia; Approved April 2001
Adderall XR; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD); Shire Pharmaceuticals; Approved October 2001 Metadate CD; Oral capsules for the treatment of attention deficit hyperactivity disorder; Celltech Pharmaceuticals; Approved April 2001
Pulmonary/Respiratory Diseases
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Invanz; Once-daily injectable treatment for bacterial infections; Merck; Approved November 2001 NasalCrom Nasal Spray; Over-the-counter nasal spray for treatment of all nasal allergy symptoms; Pharmacia; Approved April 2001 Tavist Allergy/Sinus/Headache; Oral tablet for temporary relief of symptoms associated with hay fever, allergic rhinitis, and the common cold; Novartis; Approved March 2001 Tracleer (bosentan); For the treatment of pulmonary arterial hypertension; Actelion; Approved November 2001
Bextra; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain; Pharmacia, Pfizer; Approved November 2001 Kineret; Injectable therapy for the treatment of rheumatoid arthritis; Amgen; Approved November 2001 Remicade (infliximab); For inhibiting the progression of structural damage in patients with rheumatoid arthritis; Centocor; Approved January 2001 Supartz; Joint fluid therapy for treatment of osteoarthritis in the knee; Smith & Nephew Orthopaedics; Approved January 2001
Trauma/Emergency Medicine
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