Emergent Gets Priority Review of Supplemental New Drug Application for OTC NARCAN Nasal Spray

 

• Emergent’s supplemental new drug application is the first prescription-to-over-the-counter switch application in history to be granted Priority Review by the FDA.
• NARCAN^® (naloxone HCI) Nasal Spray 4 mg, the first intranasal form of naloxone approved by the FDA in 2015, is designed for community use for the treatment of known or suspected opioid overdose.

https://www.biospace.com/article/releases/emergent-biosolutions-announces-u-s-fda-acceptance-and-priority-review-of-supplemental-new-drug-application-for-over-the-counter-narcan-naloxone-hcl-nasal-spray/