The FDA has set a PDUFA goal date of 24 March 2019 for intravenous (IV) meloxicam to manage moderate to severe pain.- Recro Pharma

Recro Pharma, Inc. announced that the FDA has set a PDUFA goal date of 24 March 2019 for its decision on the New Drug Application (NDA) for intravenous (IV) meloxicam for the management of moderate to severe pain.

Recro resubmitted the NDA for IV meloxicam in September 2018 in reply to a Complete Response Letter (CRL) received from the U.S. FDA in May 2018. The FDA�s stated reason for the CRL was that data from ad hoc analyses and selective secondary endpoints suggested that the analgesic effect of IV meloxicam does not meet the expectations of the FDA. The CRL also raised CMC-related questions on extractable and leachable data provided in the NDA. Recro believes the resubmitted NDA addresses the FDA�s concerns surrounding these items.