Watson gets approval for generic pregnancy-prevention drug

By Elaine Rigoli

Tampa, Fla., June 1 - Watson Pharmaceuticals, Inc. has received final approval from the Food and Drug Administration on its abbreviated New Drug Application for levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg / 0.02 mg, a generic version of Berlex's Levlite product, indicated for the prevention of pregnancy.

The company said it intends to start shipments of the product shortly. For the 12 months ended in March, the levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg / 0.02 mg market had total U.S. sales of about $28 million, according to IMS Health data.

Watson Pharmaceuticals, based in Corona, Calif., develops brand and generic pharmaceutical products.

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