The Food and Drug Administration did not 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.
The rejection came despite the agency’s advisory committee in May voting to recommend approval of the drug in children and adults. It’s rare that the FDA does not approve drugs recommended by its committees.
"We are very surprised by this action," Richard Lowenthal, the CEO of ARS Pharmaceuticals said in the statement.
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The company said it is going to appeal the FDA's request for additional data.
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