News
Adamis Pharmaceuticals resubmits NDA for Zimhi for the treatment of opioid overdose..
Adamis Pharmaceuticals Corporation announced the resubmission of the Company’s New Drug Application (“NDA”) to the FDA for its Zimhi (naloxone HCI Injection, USP) 5mg/0.5mL product candidate for the treatment of opioid overdose.
The resubmission follows the company’s meeting with the agency in February and is intended to address the issues raised by the FDA in the agency’s November 2019 Complete Response Letter (“CRL”). Adamis previously announced that it entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC (“USWM”) for commercial rights for the ZIMHI product candidate.
Condition: Opioid Dependence/Overdose
Type: drug
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