2020-12-01 09:14:17 ADMP Adamis Pharmaceuticals
12/01/20 12/0109:14 12/01/2009:14 | Adamis Pharmaceuticals intends to address all deficiencies in ZIMHI CRLAdamis Pharmaceuticals Corporation announced a planned response to a Complete Response Letter (CRL) from the U.S. Food and Drug Administration, regarding its New Drug Application for Adamis' ZIMHI high dose naloxone injection product for the treatment of opioid overdose. The CRL, received November 13, 2020, identified deficiencies that the FDA determined must be corrected before the Agency can approve the NDA, and provided recommendations needed for resubmission. FDA had not previously identified those deficiencies. Adamis intends to address all the deficiencies raised in the CRL and request that FDA approve the NDA. All of the company's responses to the deficiencies will be submitted before year end. The company will then ask the FDA for a Type A meeting. If the matter cannot be resolved with the FDA Division that sent the CRL, Adamis intends to appeal the matter within the agency through a Formal Dispute Resolution. |
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