FDA delays approval of Envarsus XR for Transplant Rejection-Veloxis

The FDA has informed Veloxis of the tentative approval of Envarsus XR (tacrolimus extended relief) for Transplant Rejection. The FDA stated that the final approval of Envarsus XR will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL. Veloxis understands that this expiry is anticipated to occur July 19, 2016. The FDA's approval notice stated that it is "subject to change on the basis of any new information that may come to FDA's attention." Veloxis disagrees that exclusivity for Astagraf XL, which was not identified as a listed drug or relied upon to support approval of Envarsus XR, should require delay in the formal approval of Envarsus XR. Veloxis plans to immediately appeal this decision within FDA, and will pursue all options available to it.