FDA CRL - Xspray Pharma AB

The FDA has issued a Complete Response Letter for Xspray Pharma AB’s New Drug Application (NDA 216195) for their dasatinib tablets, indicating it cannot be approved in its current form. A primary concern is clinical and labeling safety. Labeling comprehension studies failed to demonstrate that the proposed labeling enables safe switching between dasatinib products or safe treatment initiation. The FDA found the company's proposed risk mitigation strategy of adding a descriptor to the product name ineffective in preventing medication errors. The agency recommends exploring alternative risk mitigation strategies for product nomenclature and labeling, and advises a meeting prior to initiating further studies. Facility inspections also revealed significant issues. A pre-approval inspection of a manufacturing facility identified deficiencies (documented in an FDA Form 483) that compromise the facility’s ability to perform its designated functions. These deficiencies must be satisfactorily addressed by the facility and their responses submitted to the FDA before Xspray Pharma AB can resubmit the NDA. Additionally, the FDA requires several labeling adjustments, including adding a specific statement about the Medication Guide to carton and container labeling. A comprehensive safety update is also mandated, requiring detailed submission of all new nonclinical and clinical safety data, analyses of adverse events, trial discontinuations, and worldwide safety experience. Comments on the main prescribing information and proprietary name are reserved until other issues are resolved. Xspray Pharma AB must address all identified deficiencies and submit a complete response within one year.