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Lysteda Approval History

  • FDA approved: Yes (First approved November 13th, 2009)
  • Brand name: Lysteda
  • Generic name: tranexamic acid
  • Dosage form: Tablets
  • Previous name: XP12B
  • Company: Xanodyne Pharmaceuticals, Inc.
  • Treatment for: Menorrhagia

Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.

Development History and FDA Approval Process for Lysteda

Nov 16, 2009Approval Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding
Apr  2, 2009Xanodyne's New Drug Application for XP12B the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification

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