nnoPharma Licensing LLC: Acetaminophen njection

November 4 and 14, and December 19, 2014, and January 9, and February 5 and 9, 2015.

We also acknowledge receipt of your amendment dated February 13, 2015, which was not reviewed for this action.

1. You have not provided adequate nonclinical safety justification for the drug product formulation.

To address this deficiency, conduct a 28-day repeat-dose intravenous toxicology study in a single species with the drug product formulation that includes all standard toxicological endpoints and an assessment of the local tissue toxicity of the drug product.

Ideally, the study would mimic the clinical dosing regimen as closely as possible, define a NOAEL, and define the toxicological profile of the drug product formulation.

In addition, conduct an in vitro blood compatibility assessment of the drug product to demonstrate that the drug product formulation does not result in red blood cell hemolysis, flocculation of proteins, or aggregation of platelets.

Submit draft labeling that addresses our proposed revisions in the attached labeling.