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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

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

Further information

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