Expected to be available in Canada in the third quarter of 2013, Fibristal becomes the first approved medication to reduce fibroid size in addition to controlling symptoms.
Actavis Specialty Brands president Fred Wilkinson said, "The approval of Fibristal marks our entry into this important therapeutic area, and provides an innovative new treatment option for women whose fibroid-symptom severity often leads to excessive bleeding and related pain."
Two double-blind, controlled, multicenter, Phase III studies demonstrated the efficacy and safety of Fibristal, which was shown to significantly reduce heavy bleeding during menstruation, pain and discomfort and the overall volume of fibroids.
Following three-month treatment with Fibristal, the shrinkage in fibroid size was maintained for a minimum of six months.