Adamis To Resubmit NDA For ZIMHI Within 45 Days - Quick Facts

(RTTNews) - Adamis Pharmaceuticals Corporation (ADMP) issued an update on the status of the NDA for ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. The company had a Type A meeting with the FDA to review comments on the additional information provided by the company in response to the FDA's Complete Response Letter. Adamis said it believes the meeting was productive and plans to resubmit the NDA for ZIMHI to the FDA within the next 45 days.

Dennis Carlo, CEO of Adamis Pharmaceuticals, said: "We believe we obtained critical feedback from the FDA at our Type A meeting on a number of issues and also received an acknowledgement of the agency's intention to commit to a rapid review of the NDA."