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BRIEF-Aerie Pharmaceuticals comments on notification from contract manufacturer
August 8, 2017 / 8:32 PM / 4 months ago

BRIEF-Aerie Pharmaceuticals comments on notification from contract manufacturer

Aug 8 (Reuters) - Aerie Pharmaceuticals Inc

* Aerie Pharmaceuticals Inc - ‍received notification by its contract drug product manufacturer that contract manufacturer received CRL from U.S FDA

* Aerie Pharmaceuticals - ‍CRL from FDA regarding contract manufacturer’s NDA for one of their own product candidates manufactured at Tampa, Florida facility​

* Aerie Pharmaceuticals Inc - ‍according to contract manufacturer, CRL refers to a Current Good Manufacturing Practice (CGMP) inspection at facility​

* Aerie Pharmaceuticals Inc - ‍contract manufacturer has stated that they will work closely with FDA to determine appropriate next steps​

* Aerie Pharmaceuticals Inc - ‍currently believe it is probable that open issues will be resolved prior to February 28, 2018 PDUFA date for Rhopressa​ Source text for Eikon: Further company coverage:

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