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US FDA okays Watson Pharma's levonorgestrel, ethinyl estradiol tabs
Corona, California | Tuesday, November 23, 2004, 08:00 Hrs  [IST]

Watson Pharmaceuticals Inc., a leading specialty pharmaceutical company, has received final approval from the US FDA on its Abbreviated New Drug Application for levonorgestrel and ethinyl estradiol tablets USP, 0.1mg / 0.02mg, a generic version of Wyeth's Alesse, which is indicated for the prevention of pregnancy.

The Company intends to initiate shipments of the product immediately under the trade name Lutera. For the 12-months ending September 2004, the levonorgestrel and ethinyl estradiol tablets USP, 0.1mg / 0.02mg market had total U.S. sales of approximately $163 million, according to IMS Health data.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products.

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