Astellas Finally Wins FDA Approval For Prograf Successor
This article was originally published in The Pink Sheet Daily
Executive Summary
Female mortality rate among liver transplant patients had been a major obstacle to approval for extended-release tacrolimus, which was first filed in 2005. But the once-daily drug is now approved for kidney transplant patients.
You may also be interested in...
FDA Exclusivity Protections Blocking ‘Me Too’ Product Challenged In Lawsuit
Veloxis sues FDA after agency declines to approve to its extended-release immunosuppressant, Envarsus XR, until exclusivity for Astellas’ Astagraf XL expires in 2016.
Astellas Tacrolimus Approval Remains At Bay
On heels of second “approvable” letter for kidney transplant rejection, FDA issues another approvable for liver indication.
Astellas’ Once-Daily Tacrolimus Again “Approvable” For Kidney Transplant Patients
Extended FDA review period up soon for long-lasting Prograf in liver transplant patients.