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The US FDA approves first generic EpiPen for the emergency treatment of allergic reactions
17 August 2018 -

Public health company The US Food and Drug Administration Thursday authorised the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds.

The US FDA's approval to market the generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths was awarded to Teva Pharmaceuticals USA.

Life-threatening allergies can include reactions to insect bites or stings, foods, medications, latex or other causes. Anaphylaxis is a medical emergency that affects the whole body and, in some cases, leads to death. People who have had an anaphylaxis episode must carry an emergency dose of epinephrine at all times.

According to the company, the EpiPen is intended to automatically inject a dose of epinephrine into a person's thigh to stop an allergic reaction. The US FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q.

Epinephrine auto-injector products are known as "combination products" because they consist of a drug (epinephrine) and a device (the auto-injector). When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action,concluded the US FDA.



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