The Food and Drug Administration once again failed to approve Recro Pharma's new drug application for its experimental non-opioid pain medication intravenous meloxicam.
The federal agency, in its complete response letter (CRL) to the Malvern, Pa.-based pharmaceutical company, said the delayed onset of IV meloxicam fails to meet the prescriber expectations for intravenous drugs. The letter, according to Recro, also cited regulatory concerns about the role of IV meloxicam as a monotherapy in acute…
