Regulatory Focus™ > News Articles > 2019 > 4 > FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment

FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment

Posted 19 April 2019 | By Ana Mulero 

FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment

Teva Pharmaceuticals USA snagged US Food and Drug Administration (FDA) final approval for the first generic naloxone hydrochloride nasal spray known as Narcan, the agency announced on Friday.

The life-saving medication is indicated for stopping or reversing the effects of an opioid overdose and the approval forms part of the agency’s ongoing efforts to combat the nation’s opioid crisis. Generic injectable naloxone products are already in use at health care settings, but the approval marks the first generic naloxone nasal spray for an individual without medical training to use in a community setting.

“In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone,” Douglas Throckmorton, deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research says, pointing to the opioid crisis.

The agency announced new steps earlier this year to promote greater availability of naloxone for over-the-counter use. Throckmorton notes that, as part of the new efforts, FDA is considering co-prescription of naloxone for all or some opioid prescriptions to reduce the risk of overdose death. An FDA advisory committee voted in favor of adding the labeling language to recommend co-prescriptions in December 2018. FDA is also planning to prioritize review of applications for generic drugs to treat opioid overdose.

“We’re taking many steps to improve availability of naloxone products, and we’re committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction,” says Throckmorton.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe