Thursday, April 2, 2009

Xanodyne's New Drug Application for the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification

Xanodyne Pharmaceuticals, Inc. announced today that the U.S. FDA has accepted for filing and granted priority review status for its investigational proprietary formulation of tranexamic acid for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms. On January 30, 2009, Xanodyne submitted the New Drug Application (NDA) for XP12B, a unique oral therapy which acts as a competitive plasmin inhibitor to prevent fibrinolysis by binding to the lysine receptor sites of plasminogen.

The details can be read here.

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