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Allergan's Ulipristal, Dogged By Liver Concerns, Gets An FDA Rejection

 
• By Jessica Merrill

US FDA issued a complete response letter for ulipristal acetate for the treatment of bleeding in women with uterine fibroids. The action wasn't unanticipated, but a disappointment nonetheless while Allergan tries to sell its women's health unit.

Female uterus and ovaries abstract background.

A US FDA complete response letter (CRL) for Allergan PLC's ulipristal acetate in the treatment of abnormal uterine bleeding in women with uterine fibroids removes an overhang on the company's effort to sell its women's health unit, but it will also negatively impact any potential valuation of the business.

The company announced the receipt of a CRL in response to a new drug application (NDA) for ulipristal Aug. 21, which was not a surprising development but a disappointing one for Allergan nevertheless

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