FDA CRL - RiconPharma LLC

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Ricon Pharma, LLC, as agent for Ingenus Pharmaceuticals, LLC, for their New Drug Application (NDA 212501) concerning Cyclophosphamide Injection. The FDA determined that the application cannot be approved in its current form due to several outstanding deficiencies.A primary issue involves unresolved deficiencies identified during a recent inspection of the manufacturing facility. Satisfactory resolution of these findings is mandatory for approval. Furthermore, the proposed Prescribing Information (PI) does not adhere to the content and format regulations outlined in 21 CFR 201.56(a) and (d) and 201.57. Revisions are also required for the carton and container labeling.To address these deficiencies, Ricon Pharma must resolve all manufacturing facility issues, submit a revised PI that conforms to regulatory guidelines, including structured product labeling (SPL) format, and update the carton and container labeling based on FDA's proposed revisions. The company is required to resubmit the application or take other actions within one year under 21 CFR 314.110 and may request a meeting with the FDA to discuss the necessary steps. The drug product cannot be legally marketed until written approval is obtained.