PITTSBURGH — Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.
The generic drug maker said it filed a motion in the U.S. District Court for the District of Columbia Tuesday to stay the court's order, which called on the FDA to let Watson launch a generic version of Takeda's Type 2 diabetes drug Actos (pioglitazone).
"Mylan is disappointed in yesterday's ruling regarding pioglitazone, and we believe the court erred in its decision by directly contravening the Hatch-Waxman Act," Mylan CEO Heather Bresch said, referring to the 1984 law that created an abbreviated approval pathway for generic pharmaceutical drugs. "Mylan does not believe Watson is entitled to participate in Mylan's 180-day exclusivity period in relation to this product, and we intend to pursue this case vigorously, including seeking expedited relief from the appellate court if necessary."
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.