Veloxis Pharmaceuticals transplant news

Veloxis 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 tacrolimus XR. In October, Veloxis said FDA granted tentative approval to an NDA for Envarsus to prevent organ rejection in kidney patients, but said final approval will be delayed until expiration of the exclusivity period of Astagraf XL tacrolimus from Astellas Pharma Inc. (Tokyo:4503, Tokyo, Japan.). Veloxis expects exclusivity for Astagraf XL to expire on July 19, 2016 (see BioCentury, Nov. 3).

According to the suit, Veloxis believes Astagraf XL is not entitled to exclusivity and that FDA’s failure to immediately approve Envarsus XR exceeds its statutory authority. Specifically, Veloxis argues Astagraf XL did not meet the statutory test for exclusivity for antibiotic-containing compounds based on the date Astellas submitted in its NDA. Veloxis is seeking an injunction ordering FDA to rescind the marketing exclusivity awarded to Astagraf XL. ...