ADMP - Adamis Pharma soars 18% after FDA accepts Zimhi application for review

The FDA has accepted for review Adamis Pharmaceuticals' (ADMP) resubmitted New Drug Application ((NDA)) for Zimhi, which is its higher naloxone injection product candidate for the treatment of opioid overdose.ADMP shares surge 18% premarket trading at $1.19.The FDA also provided PDUFA target action date of November 12, 2021.The Agency had completed its filing review and had determined that the NDA was sufficiently complete to permit a substantive review. “We look forward to working collaboratively with the FDA during the review process to support the case for approval of ZIMHI,” said Dr. Dennis J. Carlo, President and CEO.Last month, the company resubmitted NDA for Zimhi after it received complete response letter last year related to Chemistry, Manufacturing and Controls issues.

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Adamis Pharma soars 18% after FDA accepts Zimhi application for review