FDA Drops Age Limit for Neffy
Needle-free epinephrine expands access for younger children meeting weight criteria
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By
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Kathryn Wighton
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March 27, 2026
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The FDA has removed the minimum age requirement for the 1 mg dose of Neffy, expanding access to younger pediatric patients.
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Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, for patients weighing 33 pounds or greater.
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Approximately 25% of patients needing epinephrine are younger than 4 years and weigh between 33 to less than 66 pounds.
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Updated guidance recommends carrying two Neffy devices and provides instructions for administration and storage.
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Neffy remains stable during temperature excursions up to 122 °F and can be used after thawing if previously frozen.
