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# FDA Issues Allergan ‘Complete Response’ on Fibroid Drug
- URL: https://www.fdaweb.com/fda-issues-allergan-complete-response-on-fibroid-drug/
- Published: 2018-08-22T12:00:00.000Z
- Updated: 2026-09-15T00:27:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142173

FDA has issued Allergan a complete response letter on its NDA for ulipristal acetate, indicated for treating abnormal uterine bleeding in women with uterine fibroids. The letter requests additional information and cites safety concerns regarding post-marketing reports outside the U.S., according to the company. Allergan plans to meet with the agency to discuss the comments and next steps.

The NDA included data from two U.S. Phase 3 clinical trials and all Phase 3 EU registration studies as well as real-world data in more than 700,000 women with uterine fibroids across 80 countries worldwide, the company says. Ulipristal acetate is a selective progesterone receptor modulator, which acts directly on the progesterone receptors in three target tissues: the endometrium (uterine lining), uterine fibroids, and the pituitary gland.