Supplier News Breaks
Watson cleared to release Lysteda generic
January 3rd, 2013
PARSIPPANY, N.J. – Watson Pharmaceuticals Inc. has received approval from the Food and Drug Administration for tranexamic acid tablets, a medication for menstrual bleeding.
The company said Thursday that it will immediately begin shipping the product, which is a generic equivalent to Ferring Pharmaceuticals' Lysteda.
Watson also reported that Ferring B.V. has filed lawsuits against it, alleging that Watson's ANDA (Abbreviated New Drug Application) product infringes U.S. Patent Nos. 7,947,739, 8,022,106, and 8,273,795. The litigations are pending, Watson said.
Lysteda is indicated for the treatment of cyclic heavy menstrual bleeding. For the 12 months ended Nov. 30, Lysteda had total U.S. sales of about $25 million, according to IMS Health figures cited by Watson.
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