Watson Pharmaceuticals, Inc, a leader in generic and specialty branded pharmaceuticals, announced that its subsidiary, Watson Laboratories, 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 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. For the 12-months ending September 2008, Mircette had total US sales of approximately $135 million, according to IMS Health data.
Watson Pharmaceuticals, Inc. is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes generic and specialty brand pharmaceutical products.