Aerie Pharmaceuticals reported that it has been notified by its third party manufacturing vendor that the manufacturing line related to Rhopressa in their Tampa, Florida facility will not be ready for pre-approval inspection by the FDA until the end of February 2017. In October 2016, the Rhopressa new drug application was withdrawn due to the contract drug product manufacturer not being prepared for pre-approval inspection by the FDA. The contract drug product manufacturer had previously advised Aerie and the FDA that it expected to be prepared for FDA inspection in January 2017. The delay apparently does not result from any new findings, but rather additional time needed to complete validation of new equipment.
Aerie now expects to resubmit the Rhopressa NDA filing near the end of the first quarter of 2017 after receiving notification from the contract drug product manufacturer that the manufacturing line related to Rhopressa at the Tampa, Florida site is inspection ready.