News
Zimhi resubmitted NDA is accepted by the FDA for the treatment of opioid overdose.-Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation announced that the FDA has accepted for review the Company’s resubmitted New Drug Application (NDA) for Zimhi, which is its higher naloxone injection product candidate for the treatment of opioid overdose.
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 also provided a target action date under the Prescription Drug User Fee Act (PDUFA date) of November 12, 2021.
Condition: Opioid Dependence/Overdose
Type: drug
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