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Watson Pharma's Generic Lysteda Receives FDA Approval

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Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc. – Florida has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for tranexamic acid tablets, the generic equivalent to Ferring Pharmaceuticals' Lysteda®.  

Watson intends to begin shipping the product immediately.  Lysteda® is indicated for the treatment of cyclic heavy menstrual bleeding.  Ferring B.V. has filed lawsuits against Watson, alleging that Watson's ANDA product infringes U.S. Patent Nos. 7,947,739, 8,022,106, and 8,273,795.  The litigations remain pending.

For the 12 months ending November 30, 2012, Lysteda® had total U.S. sales of approximately $25 million according to IMS Health data. 

Posted-In: News FDA


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