Denmark’s Veloxis Pharmaceuticals A/S announced that it has filed an action in federal district court for the District of Columbia against the U.S. Food and Drug Administration, seeking an order requiring the FDA to grant final approval to Envarsus® XR. 

 Envarsus XR is 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, the 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 in 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.