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FDA approves first generic naloxone nasal spray to treat opioid overdose

Christian Fernsby |
The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose.

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The agency is also 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.

The approval is the first generic naloxone nasal spray for use in a community setting by individuals without medical training; however, generic injectable naloxone products have been available for years for use in a health care setting.

The FDA also has previously approved a brand-name naloxone nasal spray and an auto-injector for use by those without medical training.

While business and other considerations may impact how quickly this product becomes available, today's approval is an important step for the agency as it works toward expanding access to this live-saving drug.


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