Aerie Pharmaceuticals says it has received notification by its contract drug product manufacturer that the contract manufacturer received a Complete Response Letter (CRL) from the U.S. FDA regarding the contract manufacturer’s New Drug Application (NDA) for one of their own product candidates manufactured at their Tampa, FL facility. According to the contract manufacturer, the CRL refers to a Current Good Manufacturing Practice (CGMP) inspection at the facility. The contract manufacturer has stated that they will work closely with the FDA to determine the appropriate next steps.

This facility also manufactures on a contract basis Aerie’s product candidate Rhopressa (netarsudil ophthalmic solution) 0.02%, which has a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2018. Based on Aerie’s understanding of the contract manufacturer’s CAPA (Corrective and Preventative Actions) and other activities at the manufacturing site, and PDUFA dates later in 2017 for other products manufactured at that site, Aerie says it is probable that open issues will be resolved prior to the February 28, 2018 PDUFA date for Rhopressa.