Veloxis sues FDA over tacrolimus delay

Veloxis Pharmaceuticals A/S (CSE:VELO) filed suit in the U.S. District Court for the District of Columbia seeking an order requiring FDA to grant final approval to immunosuppressant Envarsus XR tacrolimus and allow Envarsus XR to be immediately approved for sale in the U.S.

In October, FDA sent Veloxis a tentative approval letter for once-daily Envarsus XR, which delayed final marketing approval until exclusivity expires for once-daily Astagraf XL tacrolimus from Astellas Pharma Inc. (Tokyo:4503) on July 19, 2016 (see BioCentury Extra, Oct. 31). ...