Aerie Pharmaceuticals comments on status of contract manufacturer for Rhopressa
Aerie Pharmaceuticals has received notification by its contract drug product manufacturer that the contract manufacturer has received a Complete Response Letter from the FDA, regarding the contract manufacturer's New Drug Application for one of their own product candidates, and which refers to a Current Good Manufacturing Practice inspection at the facility. The contract manufacturer will work with the FDA to determine the appropriate next steps. This facility also manufactures on a contract basis Aerie's product candidate Rhopressa, which has a Prescription Drug User Fee Act goal date of February 28, 2018. Aerie currently believes it is probable that open issues will be resolved prior to the February 28, 2018 PDUFA date for Rhopressa.