US approval for Watson's Mircette generic
This article was originally published in Scrip
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received final approval from the US FDAfor its ANDA on desogestrel/ethinylestradiol and ethinylestradiol tablets USP 0.15mg/0.02mg, a generic version of Duramed Pharmaceuticals' low-dose monthly oral contraceptive Mircette. Watson intends to launch its product in January 2009 under the brand name Azurette. For the 12 months ending September 2008, Mircette had total US sales of approximately $135 million, according to IMS Health data.