The U.S. Food and Drug Administration (FDA) has approved Richmond-based Kaléo’s supplemental drug application for the first epinephrine auto-injector specifically for infants and children with serious allergic reactions.
The AUVI-Q 0.1mg is designed to treat life-threatening allergic reactions for children who weigh between 16.5 and 33 pounds.
The company’s auto-injector received priority review by the FDA, an expedited regulatory pathway.
Children who are treated with a standard needle length are at risk of having the needle strike the bone, according to a study published in Allergy, Asthma & Clinical Immunology. Kaléo’s AUVI-Q 0.1 mg also provides a lower dosage of epinephrine.
