The Food and Drug Administration has not approved an epinephrine nasal spray that would have been the first needle-free alternative to epinephrine auto-injectors, including EpiPens.
The agency told drugmaker ARS Pharmaceuticals that it needed to conduct another study of the drug, called Neffy, to support its approval, the company said in a statement Tuesday evening.
The rejection came despite the agency’s advisory committee voting in May to recommend approval of the drug in children and adults. It is rare for the FDA not to approve drugs recommended by its committees.
“We are very surprised by this action,” Richard Lowenthal, CEO of ARS Pharmaceuticals, said in the release.
The company said it will appeal the FDA’s request for additional data.
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