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FDA Approves First Generic Naloxone Nasal Spray

The Food and Drug Administration recently approved the first generic naloxone nasal spray, an emergency treatment for opioid overdose intended for use in the community. Generic injectable naloxone products have been available for use in health care settings for years. The FDA has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training. “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,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs at the FDA’s Center for Drug Evaluation and Research.

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