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Watson launches generic version of Actos

Court ordered FDA to grant approval for launch amid objection by Mylan

PARSIPPANY, N.J. – The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

Watson announced the launch of pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period ended in August, according to IMS Health.

The launch follows a decision by the U.S. District Court for the District of Columbia to order the FDA to allow the launch. Watson filed suit against the FDA in August 2012, alleging that an agency decision to deny Watson's claim to shared exclusivity with Mylan in marketing a generic version of Actos would improperly delay its launch of the drug. Mylan itself had attempted to intervene to stop the launch of the drug by filing a motion in the court to stay the court's order. 

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