17 May 2021 - Adamis Pharmaceuticals today announced that the new drug application was resubmitted to the U.S. FDA for Zimhi, a naloxone injection product candidate intended for the treatment of opioid overdose.

“Based on FDA feedback received during our Type A meeting in April, we have resubmitted our new drug application for Zimhi, which I am confident fully addresses the issues raised in the 13 November 2020 Complete Response Letter,” said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals. 

“We are committed to working collaboratively with the agency as it conducts its review of the resubmitted new drug application. I continue to believe the availability of additional naloxone products, especially our higher dose intramuscular injection product, which has definite advantages over the two approved intranasal products, could potentially save thousands of lives.”

Read Adamis Pharmaceuticals press release