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# FDA Rejects NDA for Recro Meloxicam
- URL: https://www.fdaweb.com/fda-rejects-nda-for-recro-meloxicam/
- Published: 2018-05-24T12:00:00.000Z
- Updated: 2026-09-15T00:07:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141526

FDA has issued a complete response letter to Recro Pharma for the NDA on its IV meloxicam. The company [reports](http://www.fdalawblog.net/2018/05/supreme-court-denies-cert-petition-accusing-fifth-circuit-of-sabotage-of-off-label-enforcement/?ref=fdaweb.com) that FDA said that although the pivotal Phase 3 trials demonstrated statistically significant outcomes on the primary endpoint, the agency is unable to approve the NDA in its current form. The letter also reportedly raised CMC related questions on extractable and leachable data provided in the NDA.

Company officials say they will request a meeting with FDA to discuss the issues raised in the letter and will work with the agency to find solutions.