The U.S. Food and Drug Administration (FDA) has approved a lower-dose version of the epinephrine prefilled syringe. The pen is known as Symjepi and is produced by Adamis Pharmaceuticals.
Symjepi is a 0.15 mg injection for the emergency treatment of allergic reactions (type I), including anaphylaxis. The pen is also used for stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as idiopathic or exercise-induced anaphylaxis.
The lower-dose version is intended for immediate administration in patients who weigh between 33 and 65 pounds and are at increased risk for anaphylaxis, including those who have had anaphylactic reactions in the past.
Last year, the FDA approved the 0.3-mg dose of Symjepi for use in patients who weigh 66 pounds or more.
Sandoz will distribute and commercialize Symjepi 0.15 mg injection, as well as Symjepi 0.3 mg injection, in the United States under an exclusive agreement with Adamis Pharmaceuticals.
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