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          FDA Clears First Epinephrine Autoinjector for Infants

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          The US FDA has approved the first and only epinephrine autoinjector (EAI) specifically designed for the treatment of life-threatening allergic reactions such as anaphylaxis, in infants and children weighing 16.5 to 33 pounds (7.5 to 15 kg). Approval of the sNDAfor Auvi-Q (epinephrine injection, USP) 0.1 mg was granted earlier after a priority review.

          The injection is a compact epinephrine auto-injector that has 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.

           

          Auvi-Q 0.1 mg EAI can deliver a dose of epinephrine appropriate to infants and small children weighing 16.5 to 33 pounds, with a shorter needle length to help mitigate the risk of striking bone, which could potentially cause injury or interfere with the delivery of epinephrine.

          With the approval, pediatric allergy healthcare community and parents of infants and small children with life-threatening allergies will have the ability to obtain an FDA-approved epinephrine autoinjector in the event of an allergic emergency.

          Ref: https://www.medscape.com/viewarticle/889007


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