FDA approves first generic naloxone nasal spray to treat opioid overdose

FDA on Friday gave final approval of the first generic naloxone hydrochloride nasal spray (Teva Pharmaceuticals USA). The agency gave tentative approval to this generic drug product in June 2018.

FDA on Friday gave final approval of the first generic naloxone hydrochloride nasal spray (Teva Pharmaceuticals USA). The agency gave tentative approval to this generic drug product in June 2018. Generic injectable naloxone products have been used for years in health care settings, but this is the first generic naloxone nasal spray for use in a community setting by those without medical training. FDA said it would take measures to prioritize its review of additional generic drug applications for naloxone. "FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an OTC naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be coprescribed with all or some opioid prescriptions to reduce the risk of overdose death," said Douglas Throckmorton, MD, deputy center director for regulatory programs in FDA's Center for Drug Evaluation and Research. According to CDC, nearly 400,000 people died from an opioid overdose from 1999 to 2017.