Lannett Holdings, Inc.: Cocaine Hydrochloride

We also acknowledge receipt of your amendment dated June 28, 2018, which was not reviewed for this action.

Submit a toxicological assessment justifying the safety of the maximum level achieved over the course of stability for any leachable that exceeds 5 mcg/day, taking into consideration the maximum daily dose of the drug product.

Several of your final study reports did not report the purity of the test articles.

Revise the final study reports for Study 16-01138-G2, 16-01139-G2, and 16-01140G2 to include purity information of the test articles evaluated.

In addition, you must establish a "bridge" (e.g., via comparative bioavailability data) between your proposed drug product and each listed drug upon which you propose to rely to demonstrate that such reliance is scientifically justified.