Drug news
Envarsus XR receives Orphan Drug designation from FDA for prophylaxis of organ rejection- Veloxis Pharma
Veloxis Pharmaceuticals A/S announced that Envarsus XR (extended release tacrolimus) was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. Envarsus XR received marketing authorization from the FDA on July 10, 2015 and provides a once a day tacrolimus in extended release form compared to twice a day tacrolimus. Envarsus XR was EU approved in July 2014 and is marketed there by Chiesi.