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# FDA Accepts Allergan NDA for Uterine Fibroids
- URL: https://www.fdaweb.com/fda-accepts-allergan-nda-for-uterine-fibroids/
- Published: 2017-10-10T12:00:00.000Z
- Updated: 2026-09-14T22:55:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139830

FDA has accepted an Allergan NDA for ulipristal acetate, an investigational drug for treating abnormal uterine bleeding in women with uterine fibroids. Ulipristal acetate is a selective progesterone receptor modulator that acts directly on the progesterone receptors in three target tissues: the endometrium (uterine lining), uterine fibroids, and the pituitary gland. 

The submission is based on data from 2 Phase 3 studies (Venus I and VENUS II) of more than 500 adult women of reproductive age. In addition, the drug’s efficacy has been demonstrated in a series of four, multi-center, Phase 3 European trials involving more than 1,000 women with uterine fibroids.