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Aerie resubmits NDA for Rhopressa

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Aerie Pharmaceuticals has resubmitted a new drug application for its once-daily IOP-lowering eye drop Rhopressa.

The initial filing for Rhopressa (netarsudil ophthalmic solution 0.02%) was withdrawn in October 2016 because the contract manufacturer in Tampa, Florida, was not prepared for preapproval FDA inspection, according to a company press release.

“We are delighted to have our Rhopressa NDA filing back on track, and we expect a standard 12-month FDA review process from the date of resubmission,” Vicente Anido Jr., PhD, CEO and chairman of Aerie, said in the release. “Pending approval, we anticipate product launch in the second quarter of 2018.”