Drug Criteria & Outcomes-FDA Approvals
Drug Criteria & Outcomes-FDA Approvals
These drugs and/or new indications have received final approval from the U.S. Food and Drug Administration:
- Brain cancer treatment Temodar (temozolomide) by Schering Plough. Oral capsules, granted orphan drug status in 1998, specifically approved for treatment of refractory anaplastic astrocytoma at first relapse after disease progression during treatment with procarbazine and nitrosourea. Approval follows trials in 162 patients, 54 of whom had relapsed. Of the 54, five had complete response and seven had partial response, with a median duration of 64 weeks. Dosage is five consecutive days within a 28-day cycle, beginning at 150 mg/m2 then increasing to 200 mg/m2. Available in 5, 20, 100, and 250 mg.
- Hormone replacement transdermal patch E2111 (estradiol hormone replacement) by Cygnus, Inc. Approved to treat moderate to severe vasomotor symptoms associated with menopause and treatment of vulvar and vaginal atrophy. Available in 0.05, 0.075 and 0.1 mg daily doses, the system is contraindicated for patients with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders.
- Pediatric formulation of the asthma treatment Accolate (zafirlukast) by Zeneca. New approval is for 10 mg tablet, recommended twice daily, for patients 7 or older. Approval follows initial marketing in 1996 for patients 12 or older, trials of 800 subjects, and a 52-week open label safety trial. Compared to placebo, side effects included headache (4.5% vs. 4.2%) and stomach pain (2.8% vs. 2.3%).
- New indications for HIV therapies d4T (Zerit) and ddI (Videx) by Bristol-Myers Squibb. New approval allows for both nucleoside analogs to be used together as part of first-line combination therapy with protease inhibitors and non-nucleoside analogues. Toxicity cautions with ddI include pancreatitis and optic neuritis. In combination with d4T, risks include peripheral neuropathy and liver function abnormalities.
- Fertility treatment Repronex (menotropins for injection) by Ferring Pharmaceuticals. For patients undergoing ovulation induction and in vitro protocols, human menopausal gonadotropin approved for subQ and IM injections. SubQ approval allows for self-administration of combination follicle-stimulating and luteinizing hormone. In trials, subQ administration resulted in 50% pregnancy rate within single cycle for patient undergoing in vitro fertilization.
- Fertility treatment Antagon (ganirelix acetate) by Organon Pharmaceuticals. An antagonist of gonadotropin-releasing hormone, drug prevents premature surges in luteinizing hormones (LH) in patients undergoing ovarian hyperstimulation. In trials less than 1% of patients experienced LH surge before the administration of chorionic gonadotrop ins. Dosage used in trials was the recommended 250 µg daily for an average of 5.4 days. Available in prefilled syringes 250 µg/0.5mL. Administration is subQ once daily during the early to mid follicular stage.
- Pregnancy prevention therapy Plan B (levonorgestrel) by Women's Capital Corp. For use in pregnancy prevention after unprotected intercourse or suspected contraception failure, approval follows trials showing an 89% reduction in the expected rate of pregnancy. Available in packages of two tablets, 0.75 mg, dosing regimen is one tablet within 72 hours followed by one tablet 12 hours later.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.