Following a Complete Response Letter Recro Pharma Inc. anticipates resubmitting the IV meloxicam NDA by the end of September.

Recro Pharma, Inc.provided a regulatory update following receipt of the official meeting minutes from a July 2018 Type A meeting with the FDA relating to a path forward for intravenous (IV) meloxicam, the Company�s lead product candidate for the management of moderate to severe pain. Recro had requested this Type A meeting with the FDA to address a Complete Response Letter (CRL) it received from the FDA regarding the New Drug Application (NDA) for IV meloxicam. During the meeting, Recro discussed data from ad hoc analyses and selective secondary endpoints of Recro�s clinical trials which the FDA had highlighted in the CRL, as well as CMC related questions on extractable and leachable data provided in the NDA. Based upon the discussion with the FDA as reflected in the official meeting minutes, Recro anticipates resubmitting the IV meloxicam NDA by the end of September. The NDA resubmission will incorporate revised language relating to the product label and, additional information relating to extractable and leachable items.