ICYMI: Important Announcement on Life-Saving Naloxone Nasal Spray Shelf Life Extension

January 19, 2024

The FDA announced on Wednesday that Emergent BioSolutions is extending the shelf-life of their life-saving drug, NARCAN Nasal Spray, from 3 to 4 years. Products like NARCAN are one way we’re helping to save lives and counter the fentanyl crisis. Illegal products such as counterfeit drugs and illicit Chinese vapes flood the U.S. and fuel the fentanyl crisis. 

Read the full press release from the FDA

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the proven standard treatment for opioid overdose as it is a medicine with no abuse potential, and it is not a controlled substance. NARCAN nasal spray was first approved by the FDA in 2015 as a prescription drug. In March 2023, FDA approved NARCAN 4 mg nasal spray, as the first naloxone product approved for over-the-counter, nonprescription use. The Agency also approved an initial shelf-life extension for NARCAN 4 mg nasal spray in August 2020 which extended the original product’s shelf-life from 2-years to 3-years.

“Naloxone is an important tool in addressing opioid overdoses. Today’s shelf-life extension of newly manufactured lots of Narcan 4 mg nasal spray supports the FDA’s Overdose Prevention Framework and efforts to ensure more OTC naloxone products remain available to the public,” said Marta Sokolowska, Ph.D., deputy center director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research.

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