The 8 mg IN (intranasal) naloxone product Kloxxado was approved in 2021. October 18, 2021, 4:30 AM PDT. The 2 mg dose was never marketed. Zimhi (naloxone hydrochloride) FDA Approval History - Drugs.com Adamis Pharmaceuticals (ADMP) Announces FDA Approval for ZIMHI FDA Approves Zimhi and Seglentis - Healthesystems Naloxone hydrochloride ZIMHI (approved by US FDA),is a medicine which will be administered by individuals with or without medical training to help reduce opioid overdose deaths. ZIMHI is a 5 mg dose of Naloxone. Download PDF Return to publications Top Adamis Receives FDA Approval for ZIMHI Adamis Pharma Reports FDA Approval Of ZIMHI In Treatment Of Opioid ... Adamis Pharma Reports FDA Approval Of ZIMHI In Treatment Of Opioid ... Our U.S. commercial partner, US WorldMeds, commercially launched our high dose naloxone product, ZIMHI, at the end of March. . The company's SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products both use the same injection device as used for ZIMHI and were approved by the FDA for use . Excursions between 59°F and 86° F (15°C and 30 . Action: FDA has approved ZIMHI (naloxone hydrochloride) injection as an additional option to treat opioid overdose. Zimhi is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose. Zimhi's approval is noteworthy because some studies show that higher doses of naloxone are often needed to better treat synthetic opioid overdoses. Adamis Pharmaceuticals Corporation announced that the FDA has approved Adamis' Zimhi (naloxone HCL Injection, USP) 5 mg/0.5 mL product. Initial U.S. Approval: 1971 . Sandra Levy. Adamis Receives FDA Approval for ZIMHI | ADMP Stock News