FDA CRL - MedRx, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to MEDRx USA, Inc. on July 11, 2024, for New Drug Application (NDA) 215029 concerning a topical system. The FDA found the application unapprovable in its current state, citing several deficiencies that require resolution.

Primary concerns highlighted included unresolved nonclinical issues, which are a critical area needing attention. Additionally, the FDA deferred commentary on the proposed prescribing information and carton/container labeling until all other application deficiencies are adequately addressed. While the proposed proprietary name was conditionally acceptable, its re-submission is contingent upon resolving all identified issues.

A significant required action is a comprehensive safety update, detailed under 21 CFR 314.50(d)(5)(vi)(b). This mandates providing detailed changes in the safety profile, integrating new clinical trial safety data in specified formats, retabulating trial discontinuations, and submitting case report forms and narrative summaries for severe adverse events and fatalities. Furthermore, updated exposure information and a summary of worldwide safety experience are necessary.

MEDRx USA, Inc. is required to address all deficiencies and resubmit the application within one year, as per 21 CFR 314.110. A complete response is essential to initiate a new review cycle, and the company may request a meeting to discuss the path forward. The product cannot be legally marketed without FDA approval.