Generics
The United States Food and Drug Administration approves Narcan
22 April 2019 -

The United States Food and Drug Administration (FDA) has approved its first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that is claimed to stop or reverse the effects of an opioid overdose, it was reported on Friday.

The US FDA is also planning new steps to prioritise the review of additional generic drug applications for products intended to treat opioid overdose, along with the earlier announced action to help facilitate an over-the-counter naloxone product. Naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This product can be used for adults or children and is easily administered by anyone, even those without medical training.

The FDA tentatively approved this generic drug product on 8 June 2018.

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