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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.

Development timeline for Kloxxado

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

Further information

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