The drug is not a replacement for emergency medical care, and emergency medical help should be sought as soon as possible after administering the first dose of Zimhi, even if the individual wakes up from unconsciousness. Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Zimhi is a 5 mg/0.5 ml high-dose prescription naloxone hydrochloride injection that can block or reverse the effects of opioids, including slowed breathing, extreme drowsiness, or loss of . Zimhi was approved through the 505 (b) (2) approval pathway that relied, in part, on the FDA's finding of safety and effectiveness for Opiant's Narcan (naloxone HCL injection), which had been previously approved as 0.4 mg and 2 mg doses. Adamis Pharma's ZIMHI Injection, proposed for the reversal of opioid overdose, awaits the FDA decision, due on November 15. Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that the U.S. Food and Drug Administration(FDA) has approved Adamis' ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL product. Adamis Receives FDA Approval for ZIMHI Zimhi - worldmedicinefoundation Initial U.S. Approval: 1971 . Adamis Pharmaceuticals Corporation announced the FDA has approved ZIMHI 5 mg/0.5 mL, a high-dose naloxone injection for use in the treatment of opioid overdose.The company is preparing for the full commercial launch of ZIMHI in the first quarter of 2022. Zimhi (naloxone hydrochloride) FDA Approval History - Drugs.com FDA Deems New Drug Application for ZIMHI Complete and Establishes a Target Action Date of November 12, 2021. Sandra Levy. Pharmaceuticals Corporation at 1-800-230-3935 or FDA at 1-800-FDA­ . Adamis submits IND application to FDA for Covid-19 treatment Adamis shares were up 21% to $1.35 in premarket trading. FDA rejects Adamis opioid overdose therapy Zimhi ... - pharmaphorum Adamis Pharmaceuticals Receives a Complete Response Letter PDF Review - accessdata.fda.gov US WorldMeds and Adamis Pharmaceuticals Announce U.S.