First Naloxone Generic Wins FDA Approval

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Opioid overdose drug designed to be used by people without medical training.

The FDA granted final approval for the first generic version of naloxone nasal spray to halt or reverse suspected opioid overdose in a community setting, the agency said on Friday.

The drug, which is designed to be carried and used by people without medical training, is manufactured by Teva Pharmaceuticals and received tentative FDA approval last June. Friday’s approval was part of the agency’s strategy to give priority to applications for generic drugs that treat opioid overdose and expedite over-the-counter naloxone products.

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