Adamis Pharmaceuticals Corporation: Naloxone HCI

Food, Drug, and Cosmetic Act for Naloxone HCI Injection, 5 mg/0.5 mL.

1. You have not provided adequate data to support the safe use of the proposed product ZIMHI (Naloxone HCI Injection, 5 mg/0.5 mL) pre-filled syringe for the emergency treatment of opioid overdose in community settings.

Submit your updated comprehensive use-related risk analysis (URRA) taking into consideration the changes to the user interface.

The comprehensive use-related risk analysis should include a comprehensive and systematic evaluation of all the steps involved in using your product (e.g., based on a task analysis) the errors that users might commit or the tasks they might fail to perform and the potential negative clinical consequences of use errors and task failures.

Based on this risk analysis, you will need to submit the results of a human factors (HF) validation study conducted under simulated use conditions with representative users performing necessary tasks to demonstrate safe and effective use of the product.

3. In your revision to Panel A from SNO053 (August 17, 2020) and Panel E from SNO055 (September 10, 2020) you make consistent logical and scientific arguments which are unsubstantiated by your evidence or do not clearly support your claims.

Also consider the Complete Response Deficiency 4 regarding your needle safety device as you revise your Fault Tree Analysis and consider that any changes to your device design should be considered as you address this comment.

Adamis Pharmaceuticals Corporation c/o Target Health Inc.

Food, Drug, and Cosmetic Act for Naloxone hydrochloride injection, 5 mg/0.5 mL.

We are withholding any comments on the relative bioavailability study until after you submit a response to this Complete Response letter.

Your annotated labeling submitted December 31, 2018, included the following (b) (4)

We reserve remaining comments on the proposed labeling until the application is otherwise adequate.

September 30, 2019. We reserve our comments on the acceptability of the packaging labels for the next review cycle.

(8) Provide English translations of current approved foreign labeling not previously submitted.

Note that resubmission goals will not apply to any resubmission of this application.