FDA Okays Epinephrine Auto-Injector for Small Kids
The U.S. Food and Drug Administration just approved Auvi-Q – the first epinephrine auto-injector designed to treat life-threatening allergic reactions, including anaphylaxis, in babies and small children weighing between 16½ and 33 pounds. The device is expected to become available to consumers in the first half of 2018.
Auvi-Q has a shorter needle and carries a lower dose of epinephrine (0.1 mg vs. 0.15 and 0.3 mg) than injectors currently on the market. The device also includes electronic voice instructions and visual cues to assist with administration.
First introduced in 2012, Auvi-Q was voluntarily recalled in 2015 amid concerns about inaccurate dosing. This FDA approval was granted through Priority Review, an expedited regulatory pathway reserved for products that may provide significant improvements in the safety or effectiveness of available therapies for serious conditions. According to a study cited by the manufacturer, Kaléo, there was nearly a 130 percent increase in emergency department visits for anaphylaxis in children 4 and younger between 2005 and 2014.