BendaRx USA Corporation: bendamustine

For a 505(b)(2) application that relies on FDA's finding of safety and/or effectiveness for one or more listed drugs (LDs) for approval, you must establish that such reliance is scientifically appropriate, and must submit data necessary to support any aspects of the proposed drug product that represent modifications to the LDs.

To resolve these deficiencies, you will need to conduct a comparative bioavailability/bioequivalence (BA/BE) study in humans to demonstrate that the formulation differences between the proposed drug product and the LDs do not impact overall PK/disposition and safety of the proposed drug product.

You should discuss the design, including the statistical analysis plan, of this study with the FDA prior to initiation.

Satisfactory resolution of these deficiencies is required before this application may be approved.