November 25, 2019 / 1:14 PM / 6 months ago

FDA declines to approve Adamis Pharma's Zimhi to treat opioid overdose

Nov 25 (Reuters) - Adamis Pharmaceuticals Corp said on Monday its opioid overdose treatment was rejected by the U.S. Food and Drug Administration.

In a letter to the company, the FDA raised questions about the treatment's chemistry and manufacturing but not about its safety or effectiveness, Adamis said.

The drug Zimhi is a naloxone pre-filled single dose syringe used for the emergency treatment of known or suspected opioid overdose.

Reporting by Shivani Singh and Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli

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