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Pharmaceuticals / Submissions and Approvals

FDA Approves First Generic Naloxone Nasal Spray

April 26, 2019
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The FDA announced full approval of Teva’s generic naloxone nasal spray—tentatively approved last June as the first generic spray for treating opioid overdoses —and said the agency will prioritize reviews of other naloxone generics and push for the development of an over-the-counter version.

Teva’s product is the first generic naloxone spray that can be administered by someone with no medical training. The agency previously approved a brand-name naloxone nasal spray, Adapt Pharma’s Narcan, as well as Kaleo’s Evzio auto-injector, for use by individuals without medical training.

Teva has not yet disclosed the list price of the generic spray. Narcan spray typically retails for around $130 for a two-pack.

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