FDA Approves Emergent’s 6-Count and 24-Count Over-The-Counter Narcan Packs
The FDA approved Emergent BioSolutions’ supplemental New Drug Application for over-the-counter NARCAN Nasal Spray in new 6-count and 24-count packs to boost high-volume distribution. Since its 2016 introduction, distribution has surpassed 85 million doses across the U.S. and Canada, enhancing emergency overdose response.
1. FDA Approval Details
Emergent BioSolutions gained FDA clearance for its supplemental New Drug Application enabling 6-count and 24-count multipack configurations of the NARCAN Nasal Spray 4 mg formulation, marking the first over-the-counter 4 mg naloxone option cleared for opioid overdose emergencies.
2. New Multipack Configurations
The approved packs contain six or twenty-four individual naloxone doses and are designed to streamline procurement for community health organizations, first responders and retail outlets with high-volume naloxone needs.
3. Distribution and Availability
These multipacks will be available through the company’s proprietary NARCANDirect platform and are slated for launch in the coming weeks, complementing the recently approved carrying case accessory.
4. Historical Dosage Distribution and Impact
Since its 2016 market introduction, more than 85 million NARCAN doses have been distributed across the U.S. and Canada, underscoring its role in life-saving opioid overdose interventions.