FDA CRL - WraSer Pharmaceuticals, LLC

Sedor Pharmaceuticals, LLC received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA 210864) for Sesquient (fosphenytoin sodium) injection, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application was not approved due to significant deficiencies in product quality and clinical safety data.

Key product quality issues included insufficient stability data for the diluted drug product across its proposed concentration range (1.5 mg PE/mL to 25 mg PE/mL) in both 5% dextrose and 0.9% saline, with compatibility studies only performed in saline. The analytical methods for assay and impurities, particularly related substances, were not adequately validated, hindering shelf-life determination. Missing in-process control testing results for registration batches and an absence of described risk mitigation for particulate control during manufacturing were also cited.

Clinically, the application lacked adequate information to support the safety of the excipient Captisol at the proposed infusion rates and total doses. The FDA requires more robust safety data or proper documentation if relying on a listed drug containing Captisol.

Required actions involve submitting comprehensive stability data, validating analytical methods, providing complete manufacturing control results, detailing particulate control strategies, addressing Captisol safety concerns, and submitting a comprehensive safety update. The company must also revise and resubmit proposed labeling and the proprietary name upon addressing these deficiencies.