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Esmya Approval Status

FDA Approved: No
Brand name: Esmya
Generic name: ulipristal acetate
Company: Allergan plc
Treatment for: Uterine Fibroids

Esmya (ulipristal acetate) is an oral selective progesterone receptor modulator (SPRM) in development for the treatment of uterine fibroids.

Development Status and FDA Approval Process for Esmya

DateArticle
Aug 21, 2018Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application
Feb 28, 2018Allergan Announces FDA Has Extended The Ulipristal Acetate NDA Review Period To August 2018
Oct 10, 2017Allergan Announces that the FDA Accepts New Drug Application for Ulipristal Acetate for Uterine Fibroids
Jan 17, 2017Allergan and Gedeon Richter Announce Positive Phase III Results for Ulipristal Acetate 5 and 10 mg in the Treatment of Uterine Fibroids
Feb  6, 2012NEJM features two positive pivotal trials of HRA Pharma compound ulipristal acetate for the treatment of uterine fibroids

Further information

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