Watson gets tentative approval for Crestor generic

AstraZeneca lawsuit could delay launch until 2013

MORRISTOWN, N.J. — The Food and Drug Administration has granted tentative approval to a generic cholesterol drug made by Watson Pharmaceuticals, the company said Wednesday.

Watson announced the tentative approval of Watson's rosuvastatin zinc tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of AstraZeneca's Crestor. Tentative approval means that the drug meets the FDA's conditions for approval, but the agency can't allow it to be marketed because patents covering the branded version have yet to expire.

Watson is aiming to be the first company to market a generic version of Crestor, and its regulatory approval application prompted AstraZeneca to file a patent infringement suit against it in October. AstraZeneca's suit prevents Watson from commercializing the drug and places a stay of final FDA approval on it until April 2013 or until the companies reach an agreement in court.

Crestor is one of the top-selling drugs in the country, with 2010 sales of $3.8 billion, according to IMS Health.

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