Posted by Michael Wonder on 23 Jul 2018
Aerie Pharmaceuticals announces early notification of FDA acceptance of NDA submission for Roclatan (netarsudil/latanoprost ophthalmic solution)
23 July 2018 - Aerie Pharmaceuticals today reported that it has received the “Day 74” notification from the U.S. FDA earlier than scheduled, the FDA has completed its initial 60-day review of the new drug application for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% and the FDA has determined that the application is sufficiently complete to permit a substantive review.
The PDUFA goal date for the completion of the FDA’s review of the Roclatan NDA is set for 14 March 2019. This date reflects a standard 10 month review period and is consistent with management’s expectations for the 505(b)(2) filing.
The “Day 74” notification indicated that the FDA has not identified any potential review issues, and did not mention the need for an advisory committee.
