Posted by Michael Wonder on 18 May 2020
Adamis Pharmaceuticals resubmits Zimhi new drug application to FDA
18 May 2020 - Adamis Pharmaceuticals Corporation today announced the resubmission of the Company’s new drug application to the U.S. FDA for its Zimhi (naloxone hydrochloride 5 mg/0.5 mL solution) for the treatment of opioid overdose.
The resubmission follows the company’s meeting with the agency in February and is intended to address the issues raised by the FDA in the agency’s November 2019 complete response letter.
