Aerie resubmits NDA for ophthalmic drug

2 March 2017

Eye disease specialist Aerie Pharmaceuticals (Nasdaq: AERI) has resubmitted its New Drug Application for Rhopressa (netarsudil ophthalmic solution)to the US Food and Drug Administration.

The move comes following notification by Aerie’s contract drug product manufacturer that the vendor’s Tampa, Florida facility is now ready for pre-approval inspection by the FDA for Rhopressa. As background, the RhopressaNDA was withdrawn in October 2016 due to the contract manufacturer not yet being prepared for pre-approval inspection by the FDA at that time.

“We are delighted to have our Rhopressa NDA filing back on track, and we expect a standard twelve-month FDA review process from the date of resubmission. Pending approval, we anticipate product launch in the second quarter of 2018,” said Vicente Anido, Jr, chief executive and chairman at Aerie.

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