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BRIEF-FDA Announces Preliminary Assessment That Certain Naloxone Products Have The Potential To Be Safe And Effective For Over-The-Counter Use

Reuters · 11/15/2022 10:46
BRIEF-FDA Announces Preliminary Assessment That Certain Naloxone Products Have The Potential To Be Safe And Effective For Over-The-Counter Use

- FDA:

  • FDA ANNOUNCES PRELIMINARY ASSESSMENT THAT CERTAIN NALOXONE PRODUCTS HAVE THE POTENTIAL TO BE SAFE AND EFFECTIVE FOR OVER-THE-COUNTER USE

  • FDA - ISSUED FEDERAL REGISTER NOTICE TO HELP FACILITATE DEVELOPMENT AND APPROVAL OF CERTAIN NONPRESCRIPTION NALOXONE DRUG PRODUCTS

  • FDA - NOTICE DOESN'T COVER ALL NALOXONE PRODUCTS, AS MORE DATA NEEDED ON SAFETY & EFFICACY FOR NONPRESCRIPTION USE OF HIGHER DOSE NALOXONE PRODUCTS

  • FDA-NOTICE DOESN'T COVER ALL NALOXONE PRODUCTS,AS MORE DATA NEEDED ON SAFETY,EFFICACY FOR NALOXONE SUPPLIED IN PRESENTATIONS BEFORE PRELIM ASSESSMENT

  • FDA - NOTICE REQUESTS COMMENTS FROM PUBLIC ON WHETHER THERE IS DATA TO SUPPORT SAFE AND EFFECTIVE NONPRESCRIPTION USE OF HIGHER DOSE NALOXONE PRODUCTS

Source text for Eikon:


((Reuters.Briefs@thomsonreuters.com;))