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Lysteda Approval History

FDA Approved: Yes (First approved November 13, 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

DateArticle
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

Further information

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