The FDA has approved Sucampo Pharmaceuticals’ supplemental NDA for Amitiza (lubiprostone) to treat irritable bowel syndrome with constipation in women 18 years of age or older. As a result of the approval, Sucampo Pharmaceuticals will receive a development milestone payment of $50 million from Takeda in accordance a prior licensing agreement. Sucampo Pharmaceuticals and Takeda will jointly market Amitiza in the US and Canada.
The FDA approved Watson Pharmaceuticals‘ Mixject, a new delivery system for Trelstar (triptorelin pamoate for injectable suspension), a palliative treatment for advanced prostate cancer.
