FDA approves Watson’s generic Actos

Oct 29 2012

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that Watson has launched a generic version of Actos® (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets) after receiving final approval today from the U.S. Food and Drug Administration (FDA).  Watson began shipping the product immediately.

On August 15, 2012, Watson announced that it had filed suit against the FDA challenging the Agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of Actos®.  Mylan Pharmaceuticals, Inc. subsequently intervened as a defendant in the action.  On October 22, 2012, the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson and ordered the FDA to approve Watson's ANDA.  Mylan appealed the judgment to the U.S. Court of Appeals for the District of Columbia Circuit. The Court of Appeals has denied Mylan's motion for a stay of the judgment pending the appeal.

For the 12 months ending August 31, 2012, Actos® and its generic equivalents had total U.S. sales of approximately $2.7 billion, according to IMS Health data.