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Adamis Pharma To Resubmit Zimhi US Application For Opioid Overdose Soon

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Adamis Pharma To Resubmit Zimhi US Application For Opioid Overdose Soon
  • Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has provided an update on its marketing application's status seeking approval for Zimhi's high-dose naloxone injection product to treat opioid overdose.
  • Type A meeting with the FDA was concluded. The company believes the meeting was productive and plans to resubmit the Zimhi application to the FDA within the next 45 days, absent unexpected delays.
  • The FDA did not provide a detailed timeline for review but did indicate that it would attempt to work expeditiously.
  • Last year, the company received a complete response letter from the agency regarding the Zimhi marketing application.
  • The questions raised by the FDA are generally related to new Chemistry, Manufacturing, and Controls issues.
  • Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose.
  • It works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
  • Price Action: ADMP shares are down 1.3% at $0.87 on the last check Monday.
 

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Posted-In: Briefs opioid addictionBiotech News Penny Stocks Health Care FDA General

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