Federal court orders FDA to allow Watson diabetes drug launch
PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.
Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda's Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths.
Watson filed suit against the FDA in August 2012, alleging that an agency decision to deny Watson's claim to shared exclusivity in marketing a generic version of Actos would improperly delay its launch of the drug.
Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health.