FDA Approves First Generic Version of EpiPen

Battle of the Auto-Injectors May Lead to Lower Costs for Patients

The FDA has approved the first generic version of the EpiPen and EpiPen Jr. (epinephrine,Teva) auto-injector for the emergency treatment of allergic reactions, including anaphylaxis, in adults and pediatric patients who weigh more than 33 pounds. The generic epinephrine auto-injector is available in 0.3-mg and 0.15-mg strengths.

The EpiPen is intended to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction. The FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. Some hope that the new generic approval will lead to a price reduction of Mylan’s version of the product, which dominates the market at the pharmacy counter despite its high cost. Between 2009 and 2016, Mylan raised the price of the device more than 500%, which reignited the national debate on rising drug costs.

The generic auto-injector is intended for immediate administration to patients. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. The most common side effects associated with epinephrine injection are anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache and/or respiratory difficulties. Rare cases of serious skin and soft tissue infections have been reported following use of the drug. In patients with heart disease, the use of epinephrine injection may cause angina pectoris or ventricular arrhythmias. Following the use of epinephrine injection, patients should seek immediate medical or hospital care.

Epinephrine should not be injected into the vein, buttock, fingers, hands or feet. To minimize risk of injection-site injury, movement of the leg should be limited during injection.

Sources: FDA.gov, August 16, 2018; Modern Healthcare, August 20, 2018