FDA OKs pediatric version of alternative to epinephrine

FDA has approved a lower dose of epinephrine (Symjepi—Adamis Pharmaceuticals) for children who experience allergic reactions (type 1), including anaphylaxis. The 0.15 mg injection of epinephrine is intended for patients who weigh between 33 pounds and 65 pounds.

FDA has approved a lower dose of epinephrine (Symjepi—Adamis Pharmaceuticals) for children who experience allergic reactions (type 1), including anaphylaxis. The 0.15 mg injection of epinephrine is intended for patients who weigh between 33 pounds and 65 pounds. A 0.3 mg dose was approved last year for use in patients who weigh 66 pounds or more. The approval 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, which will distribute and commercialize the two dose strengths of Symjepi in the United States under an exclusive agreement with Adamis.