FDA Approves First Generic Naloxone Nasal Spray for the Treatment of Opioid Overdose

Teva Pharmaceuticals USA has obtained the final approval of the US Food and Drug Administration (FDA) for the first generic spray of naloxone hydrochloride known as Narcan, the agency said Friday.

This vital drug is indicated to stop or reverse the effects of an opioid overdose and its approval is part of the agency's ongoing efforts to combat the opioid crisis in the country. Generic injectable naloxone products are already in use in health care facilities, but approval marks the first generic naloxone nasal spray for a person with no medical training to use in a community setting.

"In addition to this approval of the first generic naloxone spray, we will now give priority to our review of naloxone generic drug applications," said Douglas Throckmorton, Deputy Director of Regulatory Programs at the Center for Evaluation and Naloxone. search for drugs from the FDA. the opioid crisis.

The agency announced new measures earlier this year to promote greater availability of naloxone for over-the-counter use. Throckmorton notes that, as part of these new efforts, the FDA is considering co-prescribing naloxone for all or some opioid prescriptions in order to reduce the risk of overdose deaths. An advisory committee of the FDA has voted in favor of adding label wording to recommend co-orders in December 2018. The FDA also plans to give priority to reviewing applications for Generic drugs to treat an overdose of opioids.

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