Venatorx Pharmaceuticals, Inc.: NDA 217556

, Labeling Discussion Comments for carton and container labeling, which was not reviewed for this action due to identified deficiencies that precluded further discussion of labeling, In your NDA resubmission, submit draft labeling that responds to our , communication, incorporating your proposed oe , edits.

To facilitate review of your submission, provide a highlighted or marked-up copy that shows all changes, as well as a clean Word version and PDF version of the proposed revised container labels and carton labeling.