Allergan Reports Additional Approval From Health Canada For FIBRISTAL

(RTTNews) - Allergan plc (AGN) announced the company has received an additional approval from Health Canada for FIBRISTAL (ulipristal acetate, 5 mg) for the intermittent treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age. FIBRISTAL was first approved in 2013 but now the indication for the treatment of signs and symptoms of uterine fibroids has broadened with the addition of long term safety and efficacy studies.

Allergan noted that FIBRISTAL is the first and only non-surgical treatment specifically indicated to treat the signs and symptoms of uterine fibroids. In long term clinical studies, FIBRISTAL was shown to safely and effectively control excessive uterine bleeding, shrink fibroid volume and reduce the significant pain and symptom severity scores associated with symptomatic uterine fibroids. The company said the benefits appear to improve over repeated courses.