29 November 2017 - Adamis Pharmaceuticals today announced the submission of a prior approval supplement to the U.S. FDA for a paediatric version (0.15 mg) of Symjepi.
Symjepi (epinephrine) Injection 0.3 mg is an FDA-approved product, for the emergency treatment of allergic reactions (Type I) including anaphylaxis, designed for patients weighing 66 pounds or greater. The paediatric version (0.15 mg) is intended to potentially treat patients weighing 33-65 pounds.
Both Symjepi products are intended to provide two single-dose syringes of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to allergic reaction to foods (such as nuts), insect stings or bites, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis.