New FDA Approvals
January 1, 2001 2 minutes read
New FDA Approvals
These drugs have received final approval from the Food and Drug Administration (FDA):
Topical agent clobetasol propionate (Olux) foam, 0.05%, by Connetics Corp. The FDA granted approval for this agent in May 2000. It is now available for use as short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid- responsive dermatoses of the scalp.
Bisphosphonate alendronate (Fosamax) by Merck & Co. The FDA has given approval for a new once-weekly formulation of alendronate for the prevention and treatment of postmenopausal osteoporosis. The weekly doses are 35 mg for prevention, and 70 mg for treatment.
HIV-1 combination agent abacavir sulfate, lamivudine, zidovudine (Trizivir) by Glaxo Wellcome. The FDA has granted approval for the use of Trizivir in the treatment of HIV-1 infection.
In-stent restenosis agent Checkmate System by Cordis Corp. The FDA has granted approval for this intravascular brachytherapy (or radiation) system for recurrent blockages in coronary arteries previously treated with coronary artery stents. The system’s gamma-radiating Iridium-192 seeds are placed within the blocked stent for 15-20 minutes in order to interrupt the growth of scar tissue into the stent. The seeds are then removed.
Blood glucose monitor Sof-Tact by Abbott. FDA has granted approval for Sof-Tact, a new diabetes management system that is the first automated glucose monitor to provide lancing, blood collection, and glucose testing with a single button. The device also allows blood sampling from areas of the skin less sensitive than the fingertip, such as the arm.
Antihypertensive agent telmisartan and hydrochlorothiazide (Micardis HCT) by Boehringer Ingelheim Pharmaceuticals. Telmisartan is an angiotensin II antagonist (on the AT1 receptor type), and hydrochlorothiazide is a diuretic. The FDA has approved the combination for treatment of hypertension, alone or with other antihypertensives agents. The drug is available in tablets that are 40/12.5 mg and 80/12.5 mg of telmisartan/ hydrochlorothiazide, respectively.
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