Adamis submits prior approval supplement to FDA for pediatric version of Symjepi
Adamis Pharmaceuticals announced the submission of a prior approval supplement to the FDA for a pediatric version of Symjepi. Symjepi Injection 0.3mg is an FDA-approved product, for the emergency treatment of allergic reactions including anaphylaxis, designed for patients weighing 66 pounds or greater. The pediatric version is intended to potentially treat patients weighing 33-65 pounds. Both Symjepi products are intended to provide two single-dose syringes of epinephrine, which is considered the drug of choice for immediate administration in acute anaphylactic reactions to allergic reaction to foods, insect stings or bites, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis.