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Court Instructs FDA to Approve Watson’s Generic Actos

By staff


11/20/2012
US Pharm. 2012;37(11):46.

Watson Pharmaceuticals, Inc., confirmed that U.S. District Court for the District of Columbia has granted summary judgment in favor of Watson and ordered the FDA to approve Watson’s generic version of Actos (pioglitazone hydrochloride 15-mg, 30-mg, and 45-mg tablets). Watson planned to begin shipping generic Actos immediately upon receipt of final FDA approval. In August, Watson announced that it had filed suit against the FDA challenging the agency’s decision regarding Watson’s right to shared exclusivity for its generic version of Actos.
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