FDA CRL - Biothera

Conjupro Biotherapeutics Inc. received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA 218923) for irinotecan liposome injection. The agency determined it could not approve the application in its current form due to several critical deficiencies.Key issues included unresolved deficiencies identified during pre-approval inspections of the listed manufacturing facilities. The FDA requires satisfactory responses from these facilities, with the company needing to include the dates of these responses in their complete resubmission. Additionally, the FDA was unable to complete all required Office of Study Integrity and Surveillance clinical inspections due to travel restrictions.The CRL also reserves comment on the proposed prescribing information, carton and container labeling until other application deficiencies are resolved, and the conditionally acceptable proprietary name requires resubmission. A comprehensive safety update is mandated under regulatory framework 21 CFR 314.50(d)(5)(vi)(b), requiring detailed reporting of all nonclinical and clinical safety data, including significant changes, new adverse event data, reasons for trial discontinuations, case report forms for serious events or deaths, updated exposure information, and worldwide safety experience.Conjupro Biotherapeutics Inc. must fully address all identified deficiencies within one year, as per 21 CFR 314.110, or the application may be considered withdrawn. A partial response will not initiate a new review cycle. The product cannot be legally marketed until the application receives written approval from the FDA.