FDA Drops Age Limit for Neffy

Needle-free epinephrine expands access for younger children meeting weight criteria

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1

The FDA has removed the minimum age requirement for the 1 mg dose of Neffy, expanding access to younger pediatric patients.
2

Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, for patients weighing 33 pounds or greater.
3

Approximately 25% of patients needing epinephrine are younger than 4 years and weigh between 33 to less than 66 pounds.
4

Updated guidance recommends carrying two Neffy devices and provides instructions for administration and storage.
5

Neffy remains stable during temperature excursions up to 122 °F and can be used after thawing if previously frozen.