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FDA rejects first needle-free alternative to EpiPens, calling for more research

WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images) (Sarah Silbiger, 2020 Getty Images)

The Food and Drug Administration, in a surprise move, has decided not to approve an epinephrine nasal spray that would have been the first needle-free alternative to epinephrine autoinjectors, including EpiPens.

The agency told drugmaker ARS Pharmaceuticals that it needed to conduct another study on the drug, called Neffy, to support approval, the company said in a statement late Tuesday night.

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The rejection came despite the agency’s advisory committee voting in May to recommend approval of the drug in children and adults. It’s rare that the FDA does not approve drugs recommended by its committees.

For the full report, go to NBC News.


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