Aerie Pharmaceuticals has received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) earlier than scheduled, the FDA has completed its initial 60-day review of the NDA (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 (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Roclatan NDA is set for March 14, 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.
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“We are delighted with this positive news on our Roclatan NDA, and, if approved, we expect to be fully prepared to launch Roclatan using our existing sales force, which is already making excellent progress in the early months of our Rhopressa launch,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.