ARTICLE | Company News

FDA accepts Envarsus NDA

March 13, 2014 11:39 PM UTC

Veloxis Pharmaceuticals A/S (CSE:VELO) said FDA accepted for review an NDA for Envarsus tacrolimus (formerly LCP-Tacro) to prevent organ rejection in kidney transplant patients. The PDUFA date is Oct. 30. An MAA for the product -- a once-daily tablet formulation of tacrolimus delivered using Veloxis' MeltDose technology -- is already under review, with a decision expected this year. ...