Watson Sues FDA To Regain Exclusivity For Generic Actos

Law360, Washington (August 15, 2012, 2:43 PM EDT) -- Generic-drug maker Watson Laboratories Inc. sued the U.S. Food and Drug Administration on Wednesday in Washington federal court, claiming the agency is attempting to rob Watson of a 180-day marketing exclusivity period for a generic version of Takeda North America Inc.'s diabetes drug Actos.

Watson initially filed an abbreviated new drug application to market a generic form of Actos, or pioglitazone, in 2003. In March 2010, the company reached a settlement with Takeda that would allow it, Mylan Inc. and Ranbaxy Laboratories Ltd. to begin selling...
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