Watson Pharmaceuticals announced that it has filed suit against the FDA challenging the Agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of Actos. As a result of FDA's decision, Watson's abbreviated new drug application could be delayed for up to six months. Watson noted that it filed suit after communications with FDA regarding its ANDA failed to resolve the dispute and permit a timely launch. Watson maintains that FDA improperly denied the Company's shared exclusivity despite the Company directly following directions received from FDA concerning its Paragraph IV certification to certain patents at the time of its 2003 ANDA filing.
- Watson Pharmaceuticals