Lee Pharmaceuticals, Inc – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Fennec Pharmaceuticals, Inc. regarding their New Drug Application (NDA 212937) for PEDMARK (sodium thiosulfate injection), submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application, which proposes the drug for use with cisplatin, cannot be approved in its current form due to several outstanding issues. Key concerns include unresolved deficiencies identified during a recent inspection of a manufacturing facility, requiring satisfactory resolution. Additionally, the FDA noted discrepancies regarding a manufacturing process component that was removed from proposed commercial production records but present in registration batch records, necessitating clarification and revision. Clinically, the agency highlighted an increased incidence of severe hypophosphatemia and hyponatremia in patients receiving PEDMARK with cisplatin. Fennec Pharmaceuticals must provide further analysis of their safety database to rule out a causal link between these adverse events and sodium thiosulfate injection to inform product labeling. A comprehensive safety update is also mandated, adhering to 21 CFR 314.50(d)(5)(vi)(b), which includes presenting new and combined safety data, analyzing trends, providing case reports for serious adverse events, and summarizing worldwide safety experience. The proprietary name, PEDMARK, was found acceptable but must be resubmitted with the complete response. Fennec Pharmaceuticals is required to address all deficiencies and resubmit the application within one year.