FDA CRL - Vertical Pharmaceuticals, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Verrica Pharmaceuticals Inc. regarding its New Drug Application (NDA 212905) for cantharidin topical solution. Dated May 23, 2022, the letter states that the application cannot be approved in its present form due to several unaddressed issues. A primary concern involves deficiencies identified during a facility inspection, the satisfactory resolution of which is a prerequisite for approval. The FDA also reserved comments on the proposed Prescribing Information, carton, and container labeling until other application deficiencies are resolved. The proprietary name, Ycanth, was found acceptable but needs to be resubmitted once all other issues are addressed. Under regulatory framework 21 CFR 314.50(d)(5)(vi)(b), Verrica is mandated to provide a comprehensive safety update. This update must detail any significant changes in the safety profile, integrate new clinical trial data, include re-tabulations of adverse events, provide narrative summaries for patient deaths or serious adverse events, and offer an updated summary of worldwide safety experience. Verrica must address all listed deficiencies and resubmit the application within one year, in accordance with 21 CFR 314.110, or risk potential withdrawal of the application. The drug cannot be legally marketed without formal FDA approval.