Adamis resubmits opioid overdose therapy application to FDA

  Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, today announced that the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (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 NDA for ZIMHI, which I am confident fully addresses the issues raised in the November 13, 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 NDA. 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.”

https://finance.yahoo.com/news/adamis-pharmaceuticals-resubmits-zimhi-drug-113000579.html