Watson Pharmaceuticals receives tentative approval from FDA for generic Seasonale

New York, May 9 - Watson Pharmaceuticals, Inc. said it received tentative approval from the Food and Drug Administration for its Abbreviated New Drug Application for levonorgestrel/ethinyl estradiol tablets USP, 0.15 mg/0.03 mg.

Levonorgestrel/ethinyl estradiol tablets USP is the generic equivalent to Duramed Pharmaceuticals' Seasonale tablets, indicated for the prevention of pregnancy.

For the 12 months ending March 2006, Seasonale had U.S. sales of $104 million, according to IMS Health data, Watson said.

Final approval of the product is expected following the expiration of Duramed's market exclusivity on Sept. 5.

Watson is a Corona, Calif., specialty pharmaceutical company.

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