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Women's Health Weekly

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Contraception



U.S. FDA approves levonorgestrel, ethinyl estradiol for pregnancy prevention



December 23rd, 2004

Watson Pharmaceuticals, Inc. (WPI), a specialty pharmaceutical company, announced that it has received final approval from the United States U.S. Food and Drug Administration (FDA) on its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP, 0.1mg / 0.02mg.

The drug is 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...


Source: Women's Health Weekly (2004-12-23)

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