FDA OKs Pediatric Version of Alternative to EpiPen (Symjepi)

The US Food and Drug Administration (FDA) has approved a lower-dose version of the epinephrine prefilled syringe Symjepi for use in children, Adamis Pharmaceuticals has announced.



Symjepi 0.15 mg injection is indicated for the emergency treatment of allergic reactions (type I), including anaphylaxis, to 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 individuals with a history of anaphylactic reactions.

The FDA approved the 0.3-mg dose of Symjepi last year for use in patients who weigh 66 pounds or more, as reported by Medscape Medical News.


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.

The approval of Symjepi in the pediatric setting is a "huge step forward to treat children at increased risk for anaphylaxis as it represents an affordable alternative to current treatment offerings at a time when patients need access to this medicine most,” said Carol Lynch, the president of Sandoz, in a statement.

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