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Lysteda

Generic name: tranexamic acid
Treatment for: Menorrhagia

Update: Lysteda (tranexamic acid) Now FDA Approved - November 13, 2009

XP12B NDA Accepted for Filing

Xanodyne's New Drug Application for XP12B the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification

NEWPORT, Ky., April 02, 2009 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (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. This helps to normalize the hyperfibrinolytic activity often present in women with HMB.

"We are pleased with the position that the FDA has taken in granting XP12B a priority review as it reflects their recognition of the important unmet medical need which HMB represents. We look forward to working closely with the agency to further advance this important treatment option to women who suffer from menorrhagia, or heavy menstrual bleeding," said Gary A. Shangold, Chief Medical Officer of Xanodyne.

Under the Prescription Drug User Fee Act (PDUFA), drug products with priority review designation have a 6 month review clock as compared to a 10 month standard review. Upon approval, this product candidate could become the first approved pharmaceutical product in the United States specifically indicated for the treatment of menorrhagia.

HMB, or menorrhagia, represents a frequent and significant medical condition encountered by obstetricians, gynecologists and primary care physicians. Menorrhagia has been described as regular, normal intervals of menstruation with excessive volume that may exceed 80 milliliters of blood loss per menstrual cycle. At present, no pharmacotherapy has ever been approved by the FDA for the treatment of this disorder.

Xanodyne Pharmaceuticals, Inc., which commenced operations in 2001, is an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management. Xanodyne markets a portfolio of revenue generating products consisting of pharmaceuticals and a line of prenatal vitamins. Additionally, Xanodyne is advancing a late stage pipeline of product candidates targeted at significant potential markets in Xanodyne's focus areas.

CONTACT: Thomas P. Jennings, General Counsel, Xanodyne Pharmaceuticals,Inc., +1-859-342-2092

Posted: April 2009

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