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FDA accepts Roclatan new drug application

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The FDA has accepted Aerie Pharmaceuticals’ new drug application for its once-daily IOP-lowering eye drop Roclatan, the company announced in a press release.

Roclatan, a fixed-dose combination of netarsudil and latanoprost to lower IOP in patients with glaucoma or ocular hypertension, received “day 74” notification from the FDA earlier than expected, and a Prescription Drug User Fee Act date has been set for March 14, 2019, the release said.

“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,” Vicente Anido Jr., PhD, chairman and CEO of Aerie, said in the release.

The day 74 notification did not indicate any potential review issues or a need for an advisory committee, according to the release.