Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, has notified that its unit, Watson Laboratories, Inc. has received final nod 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.
The latest drug is the generic equivalent to Duramed Pharmaceuticals' Mircette(R) low-dose monthly oral contraceptive product, which is indicated for prevention of pregnancy.
California-based pharmaceutical firm intends to launch the product in early January 2009 under the trade name Azurette (TM).
As per data revealed by IMS Health, Mircette(R) had registered total U. S. sales of approximately $135 million, for the 12-months ending September 2008.
Watson Pharmaceuticals, Inc. engages in the development, manufacture, marketing, and distribution of branded and generic pharmaceutical products in the United States. As of December 31, 2007, Watson Pharmaceuticals marketed approximately 150 generic pharmaceutical products and 27 brand pharmaceutical products.
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