Adamis pharmaceuticals receives a complete response letter from the fda regarding zimhi

Adamis pharmaceuticals corporation announced that after the close of u.s. markets on november 22nd, it received a complete response letter (crl) from the u.s. food and drug administration (fda) regarding its new drug application (nda) for adamis’ zimhi™ high-dose naloxone injection product for the treatment of opioid overdose. the crl stated that the fda determined it cannot approve the nda in its present form and provided recommendations needed for resubmission. a crl is issued by the fda'scenter for drug evaluation and research when it has completed its review of a file and questions remain that preclude the approval of the nda in its current form. the questions raised by the fda related generally to chemistry, manufacturing and controls (cmc). the plan is to expand on the cmc testing that has already been provided to the fda to satisfy the crl items. no other clinical safety or efficacy issues were raised, and the new drug application will remain open until the cmc issues are resolved.
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