Watson Pharmaceuticals, Inc.
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.
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