Published on December 30, 2008 at 3:36 AM
Watson Pharmaceuticals, Inc. has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg.
Desogestrel/ethinyl estradiol and ethinyl estradiol tablets, USP, is the generic equivalent to Duramed Pharmaceuticals' Mircette(R) low-dose monthly oral contraceptive product, which is indicated for prevention of pregnancy.
Watson intends to launch the product in early January 2009 under the trade name Azurette(TM). For the 12-months ending September 2008, Mircette(R) had total U.S. sales of approximately $135 million, according to IMS Health data.
http://www.watsonpharm.com/