FDA CRL - Recro Pharma Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Recro Pharma Inc. for its New Drug Application (NDA 210583) for Meloxicam Injection, 30 mg/mL, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application, initially filed on July 26, 2017, and amended on September 24, 2018, was not approved due to significant clinical and labeling deficiencies.

The main issues involve the drug's efficacy and safety. The FDA determined that Meloxicam Injection's delayed onset (2-3 hours) and waning analgesic effect after 18 hours make it unsuitable as an IV monotherapy for acute pain and of questionable utility for 24-hour dosing in multimodal therapy. The proposed dosing based on pharmacokinetic modeling was not supported by efficacy data, and the available safety data were insufficient to support the higher drug levels associated with a potentially shorter dosing interval.

Additional requirements include revising the prescribing information to meet PLR and SRPI standards, submitting updated content in Structured Product Labeling (SPL) format, and revising carton and container labeling to include lot numbers and properly formatted expiration dates (per 21 CFR regulations). The company must also assess the applicability of Drug Supply Chain Security Act (DSCSA) product identifier guidance. While the proprietary name ANJESO was acceptable, it must be resubmitted. Recro Pharma Inc. is required to provide a comprehensive safety update when addressing these deficiencies and resubmitting the application.