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27 Aug 2012

Watson Pharma sues FDA over generic Actos ruling

Watson Pharmaceuticals believes it is entitled to shared marketing exclusivity on generic Actos.

Watson Pharmaceuticals has announced that it is suing the US Food and Drug Administration (FDA) over a ruling that could delay approval of the company's generic version of the diabetes drug Actos by up to six months.


The company says that the FDA has "improperly" denied its shared exclusivity for its generic version of Actos, despite the company following directions received from the FDA.


It believes it should be allowed to launch its generic drug on August 17th 2012 as planned, enjoying shared market exclusivity for 180 days with Mylan and Ranbaxy.


Paul Bisaro, president and chief executive officer at Watson, revealed that the company had tried to work "cooperatively" with the FDA when it learned of the agency's views on its application.


"FDA has refused to grant shared exclusivity and seeks to unnecessarily delay the launch of Watson's generic Actos product, with potential harm to consumers

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