Reuters: Regulatory News: Watson sues FDA on generic diabetes drug ruling

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Watson sues FDA on generic diabetes drug ruling Aug 15th 2012, 14:09 Wed Aug 15, 2012 10:09am EDT Aug 15 (Reuters) - Generic drugmaker Watson Pharmaceuticals Inc sued the U.S. Food and Drug Administration, challenging a ruling against Watson's generic version of a big-selling diabetes drug, Actos. Watson said that the FDA improperly denied the company's shared exclusivity on the generic version despite Watson directly following directions received from the regulator. As a result of the FDA's decision, approval could be delayed for up to six months, Watson said in a statement. Watson planned to launch its generic version of Takeda Pharmaceutical Co Ltd's Actos on Aug. 17 after a 2010 settlement with the Japanese drugmaker. The first company that files for approval of a generic version of an off-patent drug typically gets marketing exclusivity for 180 days. An FDA spokeswoman said the agency would not comment on ongoing litigation. Actos had total U.S. sales of about $2.7 billion for the twelve months ending May 31, Watson said, quoting IMS Health data.

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