Today, Adamis Pharmaceuticals Corporation provided an update on the status of the company’s NDA (New Drug Application) with regards to ZIMHI high-dose naloxone injection. The product intends to treat opioid overdose. A Type-A meeting was held by the company with the U.S. Food and Drug Administration. The meeting reviewed comments on the additional information given by the company in response to the FDA’s previous Complete Response Letter (CRL).
Adamis Pharmaceuticals believes that the meeting was in production and it plans to submit the NDA for ZIMHI to the FDA within the upcoming 45 days, providing there aren’t any unexpected delays. The FDA did not provide a detailed timeline for the review but it did not indicate any attempt to work expeditiously.
In November 2020, a CRL was sent by the FDA to the company regarding the NDA for Asamis’ ZIMHI high-dose naloxone injection product. Before the meeting, the company responded to the issues determined by the FDA that needed to be corrected before approval.