Emergent BioSolutions announced that the Food and Drug Administration (FDA) has approved an extended shelf life for Narcan® (naloxone hydrochloride; Adapt Pharma) Nasal Spray, increasing it from 24 months to 36 months.

Narcan 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. It is intended for immediate administration as emergency therapy in settings where opioids may be present.

The product is supplied as a prefilled, single dose intranasal spray containing 4mg of naloxone hydrochloride in a 0.1mL aqueous solution. The device does not require assembly or medical training.

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Recently, the FDA recommended that healthcare professionals discuss naloxone with all patients when prescribing opioid medications. The Agency also announced that drug manufacturers of opioid medications would need to add naloxone recommendations to the prescribing information.

For more information visit narcan.com.

Reference

Emergent BioSolutions announces FDA approval of Narcan® (naloxone HCl) nasal spray shelf life extension to 36 months. https://www.globenewswire.com/news-release/2020/08/17/2079086/0/en/Emergent-BioSolutions-Announces-FDA-Approval-of-NARCAN-naloxone-HCl-Nasal-Spray-Shelf-Life-Extension-to-36-Months.html. Accessed August 17, 2020.