Yasmin review extension
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's user fee deadline for a low-dose version of Schering AG's oral contraceptive Yasmin (ethinyl estradiol/drospirenone) is Nov. 16 following a three-month review extension. "According to the FDA's written notification to [U.S. subsidiary] Berlex…the extension 'will provide time for a full review' of the application," Schering AG reported July 19. The firm said it "is confident in a 2005 launch" for the product, which contains 0.02 mg of estradiol compared to 0.03 mg in currently available Yasmin. A 2004 launch was projected at the time of the October 2003 filing...
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FDA's user fee deadline for a low-dose version of Schering AG's oral contraceptive Yasmin (ethinyl estradiol/drospirenone) is Nov. 16 following a three-month review extension. "According to the FDA's written notification to [U.S. subsidiary] Berlex…the extension 'will provide time for a full review' of the application," Schering AG reported July 19. The firm said it "is confident in a 2005 launch" for the product, which contains 0.02 mg of estradiol compared to 0.03 mg in currently available Yasmin. A 2004 launch was projected at the time of the October 2003 filing.... |