Medication Monitor



Generic Name (Trade Name—Company)
Notes
August 17, 2018

Epinephrine auto-injector

(Epinephrine pen—Teva)
FDA approves first generic version of EpiPen

FDA has approved 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, in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals gained approval to market its generic epinephrine auto-injector 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. FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick, and Auvi-Q. In addition, “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names.

An authorized generic is made under the brand name’s existing new drug application using the same formulation, process, and manufacturing facilities used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product.

This epinephrine injection (auto-injector) is intended for immediate administration to patients. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine works by reducing swelling in the airway and increasing blood flow in the veins.

The most common adverse 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, use of epinephrine injection may cause chest pain or abnormal heart beats. Following 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.