Veloxis Pharma files action against FDA over Envarsus for Kidney Transplant patients

Veloxis Pharmaceuticals has filed an action in federal district court for the District of Columbia against the FDA, seeking an order requiring it to grant final approval to Envarsus XR, a once-daily extended-release tablet indicated for prophylaxis of Organ Rejection in Kidney Transplant patients. Although Envarsus XR has been found to be safe and effective, FDA determined that the period of statutory exclusivity granted to another extended-release tacrolimus product, Astagraf XL, blocks Envarsus XR from being sold in the United States until that exclusivity period expires (July 2016) as previously announced by the Company on October 31, 2014.

Veloxis believes that FDA's action is contrary to the requirements of the controlling statute, its regulations and longstanding agency precedent. Its lawsuit seeks a determination by the Court that Envarsus XR should be immediately approved for sale in the United States. There can be no assurance that Veloxis will be successful in its action against FDA.