Single dose syringe approved by FDA for emergency treatment of allergic reactions
Adamis Pharmaceuticals Corporation announced that the FDA has approved Adamis’ Epinephrine Injection USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (“PFS”) for the emergency treatment of allergic reactions (Type I) including anaphylaxis. The FDA has also approved the PFS trade name of Symjepi.
Symjepi provides two single dose syringes of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods (such as nuts), drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis.
Comment: Adamis has entered into an exclusive licensing agreement with Allergan plc’s wholly owned subsidiary, Watson Laboratories, Inc. to commercialize Adamis’ Epinephrine Pre-filled Syringe product candidate for the emergency treatment of anaphylaxis in the US.
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