Posted by Michael Wonder on 13 Apr 2021
Adamis Pharmaceuticals provides an update on Zimhi
12 April 2021 - Adamis Pharmaceuticals today provided an update on the status of the company’s new drug application relating to its Zimhi high dose naloxone injection product intended for the treatment of opioid overdose.
The company had a Type A meeting with the U.S. FDA to review comments on the additional information provided by the company in response to the FDA’s previous complete response letter regarding the new drug application, and also to obtain input from the agency concerning the resubmission of the new drug application.
Adamis believes the meeting was productive and plans to resubmit the new drug application for Zimhi to the FDA within the next 45 days, absent unexpected delays.
