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# 2nd Complete Response Letter on Adamis’ Zimhi
- URL: https://www.fdaweb.com/2nd-complete-response-letter-on-adamis-zimhi/
- Published: 2020-11-16T12:00:00.000Z
- Updated: 2026-09-14T16:36:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148091

FDA has issued Adamis Pharmaceuticals another complete response letter (CRL) on its NDA for Zimhi, a high-dose naloxone injection product for treating opioid overdose. The letter provided recommendations to support the NDA’s resubmission. “The questions raised by the FDA related generally to new chemistry, manufacturing and controls issues,” the company says. “It should be noted that no issues related to ‘extractables and leechables testing,’ that were associated with the previous initial CRL that the company received relating to the product, were noted by the FDA.” The company says it plans to provide an additional analysis and information in order to attempt to satisfy the CRL items, adding that a Type A meeting will be requested to resolve the issues.

In 11/2019, FDA issued a CRL that cited chemistry, manufacturing and controls (CMC) information ([see earlier story](https://www.fdaweb.com/complete-response-on-adamis-high-dose-naloxone/)). 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.