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# FDA Approves Kaléo’s AUVI-Q for Infants
- URL: https://www.fdaweb.com/fda-approves-kaleos-auvi-q-for-infants/
- Published: 2017-11-20T12:00:00.000Z
- Updated: 2026-09-14T23:02:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140166

FDA has approved a Kaléo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds who are at risk for or have a history of serious allergic reactions. The auto injector features a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. The new 0.1 mg-dose epinephrine auto-injector has a shorter needle length and lower dose of epinephrine than current FDA-approved 0.15 mg and 0.3 mg epinephrine auto-injectors, according to the company.