FDA CRL - Citius Pharmaceuticals, Inc.

The FDA has issued a Complete Response Letter (CRL) to Citius Pharmaceuticals, Inc. regarding its Biologics License Application (BLA 761312) for Lymphir (denileukin diftitox-cxdl) for injection. The agency determined the application could not be approved in its current form, citing several deficiencies under the Public Health Service Act framework. Key issues include unresolved product quality concerns and non-compliant prescribing information. The draft labeling did not meet formatting and content regulations (21 CFR 201.56(a) and (d), 201.57) and required submission in Structured Product Labeling (SPL) format. Furthermore, a critical inspection of a manufacturing facility was not completed during the review cycle, which is mandatory to assess Current Good Manufacturing Practice (CGMP) compliance before approval. The proprietary name, Lymphir, was deemed acceptable pending approval but must be resubmitted. To address these deficiencies, Citius Pharmaceuticals must revise the product labeling according to FDA guidelines and ensure the required facility inspection can take place. A comprehensive safety update is also mandated, requiring detailed reporting of all nonclinical and clinical study data, including significant changes in safety profiles, combined adverse event frequencies, and updated worldwide experience, as per 21 CFR 314.50(d)(5)(vi)(b). The company has one year to resubmit a complete response, fully addressing all outstanding issues.