1 March 2018 - Allergan today announced that it was notified by the U.S. FDA that the review of the new drug application for ulipristal acetate will be extended. 

The PDUFA target action date has been extended to August 2018 to provide time for a full review of the file.

Ulipristal acetate, an investigational drug in the U.S. for the medical treatment of abnormal uterine bleeding in women with uterine fibroids, 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. In the U.S, the safety and efficacy of ulipristal acetate has been evaluated in two North American Phase 3 studies (Venus I and VENUS II) of more than 500 adult women of reproductive age. Ulipristal acetate is protected by a patent that expires in 2029.

Read Allergan press release