FDA Announces Extension to Narcan Shelf Life

Emergent BioSolutions is extending the shelf life of newly manufactured Narcan (naloxone hydrochloride) 4-mg nasal spray products from three to four years. This action was taken at the request of the FDA and “is the latest of multiple steps the Agency has recently taken to prevent overdoses and reduce overdose-related deaths by expanding access to naloxone and other overdose reversal agents,” according to 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,” the FDA stated.
Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In March 2023, the 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 the nasal spray in August 2020, which extended the original product’s shelf life from two to three years.

This shelf-life extension applies only to Narcan 4-mg nasal spray products produced following today. The shelf life of products that were produced and distributed prior to this announcement is not affected and remains unchanged. Prescribers, patients and caregivers are advised by the FDA to continue to abide by the expiration date printed on each product’s packaging and within the product’s labeling.

“Naloxone is an important tool in addressing opioid overdoses,” said Marta Sokolowska, PhD, the deputy center director for Substance Use and Behavioral Health in the FDA’s Center for Drug Evaluation and Research. “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.”  

Based on a press release from the FDA.