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# Teva Gains Approval for First Generic Narcan
- URL: https://www.fdaweb.com/teva-gains-approval-for-first-generic-narcan/
- Published: 2019-04-19T12:00:00.000Z
- Updated: 2026-09-15T01:21:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143914

FDA has approved a Teva Pharmaceuticals ANDA for the first generic naloxone hydrochloride nasal spray (Adapt Pharma’s Narcan), indicated for stopping or reversing the effects of an opioid overdose. In announcing the approval, [FDA also said](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636333.htm?ref=fdaweb.com) it is “planning new steps to prioritize the review of additional generic drug applications for products intended to treat opioid overdose, along with the previously announced action to help facilitate an [over-the-counter naloxone product](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktoc-2Fyol1xtUCruHcGy4AncZTgo32TirxcXtOYx-2BGPrz-2BG6MEmboEuBdQvJADi1lEOelkPVuv4KEKHOvOr-2FECl-2BWqQZtx9A-2BPcQAVlg6MgelVxr5E51hHfr1-2Bs7yRXN3oVVh6TBsadC72zlSmoWeWp-2FMR9htmWOyMCyOqXKgRKOODfG-2FWN1FCgc0Mt9y-2BK3EQ4hOoNM1AdLDEk90vRlStW3yY%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0Ruh5Y1zfI-2FyRGf923qkr2w-2FTKtrMuNhcqQnHQyfmFR0CG12C4K6XyjEriN8FU2dJam71N0DQC7Q6ISFn3ErAYO-2BHgr0UpFusJeZlTeR3Z1Tlbqv9zhEOHrO6GLAj4rzWT-2F3RI-2B8dzF6kGHm6b7MaewYokuMig-2B4z2OS3UDxWQoy4vdO7iXwLuNCwnlvaucFRr6RKf95BkG2pj6IfT-2Fykf075v-2BfHkkVlNq-2FCdqJ7y19ZGX0uAIGRJaEelQo1VCp2d1iuZ9LnOZi6gq2QGisgZ3303-2B2ywr0hHXwpmg6F9lzPU-3D&ref=fdaweb.com).” The agency says that this is the first generic naloxone nasal spray for use in a community setting by individuals without medical training; generic injectable naloxone products have been available for years for use in a health care setting.