> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Extends Ulipristal PDUFA Target Date
- URL: https://www.fdaweb.com/fda-extends-ulipristal-pdufa-target-date/
- Published: 2018-03-01T12:00:00.000Z
- Updated: 2026-09-14T23:26:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140882

FDA has extended the PDUFA review target date for Allergan’s ulipristal acetate to 8/2018 to allow time for a full file review. The company says ulipristal is an investigational drug for treating abnormal uterine bleeding in women with uterine fibroids. It is described as a progesterone receptor modulator that acts directly on the progesterone receptors in the endometrium, uterine fibroids, and the pituitary gland. In the U.S. the drug has been evaluated in the VENUS I and VENUS II Phase 3 trials involving more than 500 adult women of reproductive age.