Sandoz Announces FDA Approval of Pediatric Dose of Symjepi

Sandoz announced the US Food and Drug Administration (FDA) has approved Symjepi (epinephrine) 0.15 mg Injection for the emergency treatment of allergic reactions in children.

Sandoz will distribute and commercialize Symjepi (epinephrine) 0.15 mg Injection, as well as Symjepi 0.3 mg Injection, in the US under an exclusive agreement with Adamis Pharmaceuticals.

Symjepi 0.15 mg Injection is indicated for the emergency treatment of allergic reactions (Type 1) 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. Symjepi 0.15 mg Injection is intended for immediate administration in patients who weigh between 33 and 65 pounds and who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

"Today's 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, President of Sandoz Inc. "We are committed to reimagining their care by bringing this valuable, life-saving medicine in a pre-filled epinephrine syringe to the US market as soon as possible."

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