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# Adamis Refiles NDA for High-dose Naloxone
- URL: https://www.fdaweb.com/adamis-refiles-nda-for-high-dose-naloxone/
- Published: 2020-05-18T12:00:00.000Z
- Updated: 2026-09-14T16:15:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146809

Adamis Pharmaceuticals has resubmitted an NDA for Zimhi (naloxone HCI injection) for treating opioid overdose. The resubmission addresses an 11/2019 complete response letter that cited Chemistry, Manufacturing and Controls (CMC) information ([see earlier story](https://www.fdaweb.com/complete-response-on-adamis-high-dose-naloxone/)), according to the company. When the letter was issued, Adamis said it planned to expand on the CMC testing, and that no other clinical safety or efficacy issues were raised. Zimhi is a high-dose naloxone injection that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness, the company says.