Watson Pharmaceuticals receives FDA approval for generic Mircette

Dec 30 2008

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.