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Zimhi FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 18, 2021.

FDA Approved: Yes (First approved October 15, 2021)
Brand name: Zimhi
Generic name: naloxone hydrochloride
Dosage form: Injection
Company: Adamis Pharmaceuticals Corporation
Treatment for: Opioid Overdose

Zimhi (naloxone hydrochloride) is a high-dose formulation of the approved opioid antagonist naloxone for use in the treatment of opioid overdose.

  • Zimhi is indicated in adult and pediatric patients for the emergency treatment of known or suspected opioid overdose with signs of breathing problems and severe sleepiness, or not being able to respond. Zimhi is intended for immediate administration as emergency therapy and is not a substitute for emergency medical care.
  • Zimhi (naloxone hydrochloride injection, USP) 5 mg/0.5 mL is a high-dose naloxone injection product. Other FDA approved naloxone injection products are available in 0.4 mg/mL and 1 mg/mL strengths.
  • Zimhi is supplied as a single-dose, prefilled syringe and administered via intramuscular or subcutaneous injection into the thigh, through clothing if necessary. An additional dose may be administered if a response is not obtained after 2 or 3 minutes. Caregivers must seek immediate emergency medical assistance after the first dose of Zimhi, and keep the patient under continued surveillance until emergency medical assistance arrives.
  • Common side effects include nausea, dizziness, lightheadedness, and elevated bilirubin levels.

Development timeline for Zimhi

Oct 18, 2021Approval FDA Approves Zimhi (naloxone hydrochloride) Injection for the Treatment of Opioid Overdose
Jun  9, 2021Adamis Provides Update on Zimhi
May 17, 2021Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA for the Treatment of Opioid Overdose
Nov 16, 2020Adamis Pharmaceuticals Receives a Complete Response Letter from the FDA Regarding Zimhi
May 20, 2020Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.