FDA approves the first generic naloxone nasal spray to treat opioid overdoses

April 29, 2019 · Optum for Workers' Compensation

On April 19, the U.S. Food and Drug Administration (FDA) approved the first generic for Narcan® Nasal Spray, the life-saving medication used for the emergency treatment of opioid-related overdose. After receiving tentative approval last June, Teva Pharmaceuticals USA Inc. has been granted final approval to market naloxone nasal spray. Teva has not yet announced when this product will be available or the cost.

Similar to the Evzio® auto-injector, the needle-free naloxone nasal spray is designed to be administered to an individual with known or suspected opioid overdose by a family member or caregiver.

Impact on workers’ compensation

As we reported on our blog in January, since the FDA has created a faster way to access over-the-treminder to all healthcare professionals and claims adjusters, these take-home naloxone products are not a substitute for emergency medical care.

For more information on the FDA approval, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

U.S. Food and Drug Administration. News & Events. Newsroom. Press Announcements. FDA News Release. FDA approves first generic naloxone nasal spray to treat opioid overdose. April 19, 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-naloxone-nasal-spray-treat-opioid-overdose