Drug news
Complete Response Letter for Zimhi high dose naloxone to treat opioid overdose.-Adamis Pharma
Adamis Pharmaceuticals Corporation announced that after the close of U.S. markets on November 22nd, it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Adamis� Zimhi high-dose naloxone injection product for the treatment of opioid overdose.
The CRL stated that the FDA determined it cannot approve the NDA in its present form and provided recommendations needed for resubmission.
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