The U.S. Food and Drug Administration (FDA) has accepted Xanodyne’s, an integrated specialty pharmaceutical company, formulation of tranexamic acid to treat menorrhagia in women and granted priority review status. Xanodyne submitted the New Drug Application 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 on January 30, 2009. Gary A. Shangold, Chief Medical Officer, Xanodyne said, "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."

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