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.