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Kloxxado FDA Approval History

Last updated by Judith Stewart, BPharm on May 2, 2021.

FDA Approved: Yes (First approved April 30, 2021)
Brand name: Kloxxado
Generic name: naloxone hydrochloride
Dosage form: Nasal Spray
Company: Hikma Pharmaceuticals USA Inc.
Treatment for: Opioid Overdose

Kloxxado (naloxone hydrochloride) nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.

  • Kloxxado is intended for immediate administration as emergency therapy in settings where opioids may be present. Kloxxado is not a substitute for emergency medical care.
  • Kloxxado (naloxone hydrochloride 8 mg per spray) contains twice as much naloxone as Narcan Nasal Spray (naloxone hydrochloride 4 mg per spray).
  • Kloxxado is administered intranasally into one nostril. Additional doses may be given if the patient remains unresponsive while waiting for emergency medical assistance to arrive.
  • Adverse reactions include abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.

Development Timeline for Kloxxado

Apr 30, 2021Approval  FDA Approves Kloxxado (naloxone hydrochloride) Nasal Spray for Emergency Treatment of Opioid Overdose

Further information

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