Amerigen announced that the Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for Tranexamic Acid Instant Release Tablets, the generic version of Ferring‘s Lysteda.

Lysteda, an antifibrinolytic, is indicated for cyclic heavy menstrual bleeding. It works by diminishing the dissolution of hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin’s matrix structure. The antifibrinolytic effects of tranexamic acid are mediated by reversible interactions at multiple binding sites within plasminogen.

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Tranexamic Acid will be available as 650mg strength tablets.

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