Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Adamis”) today provided an update on the ZIMHI™ New Drug Application (NDA) resubmission process.
On November 22, 2019, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its NDA for Adamis’ ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. The company has provided responses to the comments included in the CRL and submitted these answers to the FDA this week. With the responses, the company requested a Type A meeting with the agency and is currently waiting for the FDA to respond to this request. The next update from the company on the ZIMHI NDA resubmission process will be sometime after the FDA meeting occurs. At that time, the company would expect to have more information regarding the timeline for the full resubmission of the NDA back to the FDA.