FDA approves ARS Pharma's neffy 1 mg for pediatric allergic reactions

ARS Pharmaceuticals, Inc.

FDA approved neffy 1 mg (epinephrine nasal spray) on March 5, 2025 for children aged 4+ weighing 15-30 kg.
Approval based on trials showing PK/PD consistent with injectable epinephrine; adverse events mild/transient.
neffy 1 mg expected to be available in the U.S. by end of May 2025.
Follows prior FDA approval of neffy 2 mg (Aug 2024) for patients ≥30 kg and EU approval (Aug 2024).
Human factors studies show children as young as 10 and untrained individuals can administer effectively.

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