ARS Pharmaceuticals Inc. (SPRY) announced that the U.S. Food and Drug Administration has approved neffy 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to less than 30 kilograms.
neffy 1 mg is the first and only needle-free epinephrine treatment approved for younger children.
ARS Pharma is committed to access and affordability, and neffy 1 mg is expected to be available in the U.S. by the end of May 2025.
The approval of neffy 1 mg follows FDA approval for neffy 2 mg on August 9, 2024 for children and adults weighing 30kg, and approval for EURneffy in the EU by the European Commission on August 22, 2024.
neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.
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