FDA CRL - BendaRx USA Corporation

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to BendaRx USA Corporation on January 17, 2024, for its New Drug Application (NDA 215291) concerning bendamustine injection. The FDA determined that the application, submitted under the 505(b)(2) regulatory pathway, could not be approved in its present form due to significant nonclinical and clinical deficiencies.

The primary issues cited include the company's failure to establish a scientific bridge between its proposed drug product and the listed drugs (LDs) it references. This deficiency stems from unaddressed differences in safety and tolerability profiles, coupled with a lack of a robust pharmacokinetic (PK) bridge.

To resolve these concerns, BendaRx USA Corporation is required to conduct a comparative bioavailability/bioequivalence (BA/BE) study in humans. The company must discuss the design and statistical analysis plan of this crucial study with the FDA before initiating it. Satisfactory resolution of these nonclinical and clinical deficiencies is paramount for approval.

Additionally, the FDA reserved comments on proposed prescribing, carton, and container labeling until other issues are resolved, mandating adherence to regulatory guidelines and submission of updated content in Structured Product Labeling (SPL) format. The previously conditionally acceptable proprietary name also requires resubmission. A comprehensive safety update, detailing significant changes in the safety profile, presenting new and combined safety data, and summarizing worldwide experience, is also mandated.

BendaRx has one year from the date of the letter to resubmit a complete response addressing all identified deficiencies; failure to do so may result in the application's withdrawal. The company may request a meeting with the FDA to discuss the necessary steps for approval.