Posted by Michael Wonder on 16 Nov 2020
Adamis Pharmaceuticals receives a complete response letter from the FDA regarding Zimhi
16 November 2020 - Adamis Pharmaceuticals today announced that after the close of business and the U.S. markets on 13 November, it received a complete response letter from the U.S. FDA regarding its new drug application for Adamis’ Zimhi high dose naloxone injection product for the treatment of opioid overdose.
The letter stated that the FDA determined it cannot approve the application in its present form and provided recommendations needed for resubmission.
