FDA
FDA removes age requirement for Neffy in anaphylaxis treatment
FDA has approved an updated label for Neffy (epinephrine nasal) to remove the age requirement for emergency treatment of type I allergic reactions, including anaphylaxis. Previously, pediatric patients had to meet both age (≥4 years old) and weight (15 kg to <30 kg) requirements to use the lowest dose of 1 mg. Now the recommended dosing is strictly weight-based; all patients weighing 15 kg to <30 kg (≥33 lbs to <66 lbs) can use the 1 mg dose, regardless of age. The 2 mg dose is recommended for patients weighing 30 kg or more.
The updated label also recommends carrying Neffy in its blister packaging or in a Neffy carrying case. The manufacturer noted that a free case designed to hold two devices is available to patients at www.neffy.com and will be included with new Neffy prescriptions in the coming months. Additional updates clarify patient administration instructions as well as storage and handling requirements.
Source: ARS Pharmaceuticals, Inc. (2026, March 27). ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy® 1 mg (epinephrine nasal spray) Label