Recro Pharma announced that the FDA granted its appeal of a complete response letter to an NDA for its intravenous pain medication meloxicam.
The FDA sent the company a CRL in March for the non-opioid pain product, citing concerns about the drug’s onset and duration.
The agency noted that the delayed onset failed to meet prescriber expectations for IV drugs and cited concerns about using the drug as a monotherapy in acute pain settings.
The company filed the appeal in early September, asking for the agency to review the safety and efficacy data. The agency determined that there was enough data to support product approval, and said it would work with the company on prescribing information.