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Watson wins FDA approval for generic Yaz

Watson Pharmaceuticals Inc. has gained approval from the Food and Drug Administration for Vestura (3 mg drospirenone and 0.02 mg ethinyl estradiol), a birth control pill.

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PARSIPPANY, N.J. — Watson Pharmaceuticals Inc. has gained approval from the Food and Drug Administration for Vestura (3 mg drospirenone and 0.02 mg ethinyl estradiol), a birth control pill.

The company said Tuesday that the product, from its Watson Laboratories subsidiary, is a generic version of Bayer’s Yaz oral contraceptive.

Watson added that it’s currently in patent litigation with Bayer regarding the product.

Citing IMS Health figures, Watson reported that Yaz had total U.S. sales of $173 million for the 12 months ended Sept. 30.

Watson said Vestura is indicated for the prevention of pregnancy and for the treatment of moderate acne in women at least 14 years old only if the patient desires an oral contraceptive for birth control.

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