Posted by Michael Wonder on 08 Feb 2016
U.S. FDA acknowledges receipt of resubmission of Shire’s new drug application for lifitegrast for dry eye disease in adults
4 February 2016 - The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act goal date of July 22, 2016.
For more details, go to: https://www.shire.com/newsroom/2016/february/lifitegrast-resubmission-press-release-fda-acknowledgement-2-4-16
