FDA CRL - XTM Consulting LLC

XTM Consulting LLC received a Complete Response Letter (CRL) from the FDA on June 12, 2024, concerning its New Drug Application (NDA 218698) for metoprolol tablets. The FDA determined the application could not be approved due to several deficiencies. Primary issues cited include unresolved product quality concerns, along with inadequate proposed prescribing information and carton/container labeling. Further review of labeling is deferred until other critical issues are addressed.

A central requirement for resubmission is a comprehensive safety update, mandated under 21 CFR 314.50(d)(5)(vi)(b). This update must detail significant changes in the safety profile, integrate all new nonclinical and clinical safety data, compare new data with original submission data, and provide updated exposure information. It also necessitates a summary of worldwide safety experience, including foreign usage estimates, and English translations of approved foreign labeling. Case report forms and narrative summaries for deaths or trial discontinuations due to adverse events are also required.

XTM Consulting LLC must fully address all identified deficiencies and resubmit the application within one year to avoid potential withdrawal of the NDA. A complete resubmission is essential to initiate a new review cycle, and the company has the option to request a meeting to discuss the necessary actions.