New FDA Approvals
New FDA Approvals
These drugs and/or new indications have received final approval from the U.S. Food and Drug Administration:
Influenza treatment Relenza (zanamavir) by Glaxo Wellcome. Aviral neuraminidase inhibitor approved primarily for uncomplicated type A influenza not requiring hospitalization. Relenza has shown effectiveness for type B treatment as well. Administered as oral inhalant mixture with lactose, recommended dosage is one 5 mg blister pack per inhalation twice daily for five days, with 4% to 17% absorption reported in trials. Efficacy unknown in patients with respiratory or cardiovascular disease.
Type 2 diabetes treatment Actos (pioglitazone hydrochloride) by Eli Lilly. Second of thiazolidinedione class effective through reduction of insulin resistance, approval indicates monotherapy or combination with sulfonylureas, metformin, or insulin. Cautions include monitoring for hepatic disorders. Liver enzyme monitoring before and during treatment recommended. Dosage is 15 or 30 mg once daily (45 mg maximum). Supplied in 15 mg, 30 mg, and 45 mg tablets.
Prescription insomnia agent Sonata (zaleplon) by Wyeth-Ayerst. Approved for short-term (seven- to 10-day) administration on as-needed basis, drug is of nonbenzodiazepine class of compounds and awaits designation by Drug Enforcement Agency. Its one-hour half-life led to little to no reports of next-day grogginess during trials of some 2,800 patients. Headache, drowsiness, and dizziness were common side effects. Available in 5 mg and 10 mg doses; recommended at 10 mg for patients under 65, 5 mg for older patients.
Fertilization hormone treatment Repronex (men otropins for injection) by Ferring Pharma ceu ticals. Approved for intramuscular and subcutaneous administration in patients undergoing ovulation induction and participating in in vitro fertilization. First such drug approved for subQ administration, trials resulted in single-cycle pregnancy rates of nearly 50% in patients undergoing in vitro fertilization. Cautions include risk of ovarian hyperstimulation.
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