April 02, 2009
FDA accepts NDA for XP12B, a treatment for menorrhagiaXanodyne Pharmaceuticals announced that the FDA has accepted for filing and granted priority review for the New Drug Application (NDA) submitted for XP12B (tranexamic acid). XP12B treats menorrhagia which is also known as heavy menstrual bleeding (HMB). Typically, the FDA grants priority review to drug products, such as XP12B, that meet an important unmet medical need such as menorrhagia and HMB. Drugs granted priority reviews have a 6 month review clock as compared to a 10 month standard review.
XP12B, an oral competitive plasmin inhibitor, prevents fibrinolysis by binding to the lysine receptor sites of plasminogen. By binding with plasminogen, XP12B normalizes the hyperfibrinolytic activity often present in women with HMB.
For more information call (877) 773-7793 or visit www.xanodyne.com.