FDA accepts Adamis’ NDA of higher dose naloxone injection product candidate

Adamis Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for review the company’s New Drug Application for its higher naloxone injection product candidate for the treatment of opioid overdose. On March 14, 2019, Adamis received FDA correspondence relating to the company’s NDA stating that the Agency had completed its filing review and had determined that the NDA was sufficiently complete to permit a substantive review. The FDA further provided a target agency action date of October 31.
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