FDA expands the indication for an epinephrine nasal spray to include children four y/o and older who weigh 15kg to less than 30 kg


March 6, 2025 – The U.S. Food and Drug Administration (FDA) has approved Neffy 1 mg, an epinephrine nasal spray by ARS Pharmaceuticals, for treating anaphylaxis in children aged 4 years and older who weigh 33 to 66 lbs. This expands upon its previous August 2024 approval for patients weighing at least 66 lbs.

Neffy is now the first and only needle-free epinephrine treatment for younger children experiencing severe allergic reactions. Experts hail this as a breakthrough for pediatric allergy care.

According to ARS Pharmaceuticals, Neffy 1 mg will be available in the U.S. by the end of May 2025. Dr. David Fleischer, a leading pediatric allergist, emphasized that this approval provides a vital alternative for children who may struggle with traditional injections.

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