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Adamis answers US FDA's concerns over opioid overdose therapy Zimhi

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Adamis answers US FDA's concerns over opioid overdose therapy Zimhi

Adamis Pharmaceuticals Corp. has submitted its answers to the U.S. Food and Drug Administration's concerns after the regulator rejected the company's opioid overdose injection Zimhi.

The FDA rejected the company's therapy in November, raising questions about the chemistry, manufacturing and controls for Zimhi.

Adamis has also requested to meet the FDA in a type A meeting, a label reserved for meetings that are immediately necessary for halted drug development to continue.

The company will provide the next update to its drug application for Zimhi, a high dose of the drug blocking therapy naloxone, after the company's meeting with the FDA.