Posted by Michael Wonder on 22 Aug 2018
Allergan receives complete response letter from the U.S. FDA for ulipristal acetate new drug application
21 August 2018 - Allergan today announced it received a complete response letter from the U.S. FDA in response to the new drug application for ulipristal acetate for the treatment of abnormal uterine bleeding in women with uterine fibroids.
The letter from the FDA indicates it is not able to approve the ulipristal acetate NDA in its current form and is requesting additional information. The agency cited safety concerns regarding Esmya post-marketing reports outside the United States. Allergan plans to meet with the FDA to discuss their comments and next steps.
The new drug application for ulipristal acetate included the results of a robust clinical trial program which included 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.
