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Narcan FDA Approval History

FDA Approved: Yes (First approved November 18, 2015)
Brand name: Narcan
Generic name: naloxone
Dosage form: Nasal Spray
Company: Emergent BioSolutions Inc.
Treatment for: Opioid Overdose

Narcan Nasal Spray (naloxone) is an intranasal opioid antagonist formulation indicated for the emergency treatment of known or suspected opioid overdose.

Development timeline for Narcan

DateArticle
Apr 13, 2023NaxSwab OTC novel naloxone nasal swab successfully administered by children and adults to potentially rescue someone from an opioid overdose in study
Mar 29, 2023Approval FDA Approves Over-the-Counter Designation for Emergent BioSolutions’ Narcan Nasal Spray, a Historic Milestone for the Opioid Overdose Emergency Treatment
Dec 26, 2022New Drug Application for RiVive Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA
Dec  6, 2022Emergent BioSolutions Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for Over-the-Counter Narcan (naloxone HCl) Nasal Spray
Jan 25, 2017Approval Narcan (naloxone HCl) Nasal Spray 2mg Approved by U.S. Food and Drug Administration
Nov 18, 2015Approval FDA Approves Narcan (naloxone) Nasal Spray to Treat Opioid Overdose
Jul 29, 2015Lightlake Therapeutics Inc. Announces Adapt Pharma Limited Submits NDA to FDA for Narcan (naloxone) Nasal Spray
Jul 23, 2014Lightlake Therapeutics Inc. Files Investigational NDA For Naloxone Nasal Spray For Reversing Opioid Overdose

See also

Narcan (naloxone) Consumer information

Further information

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

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