Envarsus tacrolimus regulatory update

Veloxis said FDA granted tentative approval to an NDA for Envarsus tacrolimus XR 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. Veloxis, which is appealing the decision, said Astagraf XL was not identified as a listed drug or relied upon to support approval of Envarsus XR. The company said FDA's tentative approval notification included agreements on manufacturing, postmarketing commitments and final labeling. ...