FDA to review Allergan filing for ulipristal acetate

9 October 2017

Dublin-incorporated Allergan has announced the US FDA has accepted its new drug application for ulipristal acetate, for the treatment of abnormal uterine bleeding in women with uterine fibroids.

The application is supported by data from the VENUS Phase III clinical trial program.

Allergan expects to get a decision in the first half of 2018.

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