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Aerie Pharmaceuticals submits prior approval supplement for Rocklatan to FDA.

Aerie Pharmaceuticals has submitted a prior approval supplement to the FDA. If approved, the PAS will permit production of Rocklatan ophthalmic solution 0.02%/0.005% for sale in the U.S. in Aerie's new manufacturing plant in Athlone, Ireland. Based on FDA timelines, Aerie expects the PAS filing review to be completed within 60 days, with final PAS review in 4 months. In addition, the company anticipates a preapproval inspection of the Athlone manufacturing plant during the 4-month review. A successful inspection along with FDA approval of the supplement would allow Rocklatan to be manufactured in Athlone for sale in the U.S. in the first half of 2020. The company also plans to file a PAS in the first half of 2020 to obtain FDA approval to manufacture Rhopressa ophthalmic solution 0.02% in Athlone. Rocklatan was approved by the FDA in the U.S: on March 12 and the commercial launch in the United States occurred on May 1.

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Publication:The Fly
Geographic Code:4EUIR
Date:Sep 19, 2019
Words:162
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