FDA OKs First Generic Version of EpiPen

Megan Brooks


August 16, 2018

The US Food and Drug Administration (FDA) has approved the first generic version of Mylan's EpiPen and EpiPen Jr (epinephrine) autoinjector for emergency treatment of allergic reactions, including anaphylaxis, in adults and in children weighing at least 33 pounds.

Teva Pharmaceuticals USA gained approval to market its generic epinephrine autoinjector in 0.3-mg and 0.15-mg strengths.

"Today's approval of the first generic version of the most widely prescribed epinephrine autoinjector in the US is part of our long-standing commitment to advance access to lower-cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval," FDA Commissioner Scott Gottlieb, MD, in a statement.

"This approval means patients living with severe allergies who require constant access to lifesaving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," said Gottlieb. The United States has recently experienced shortages of Mylan's EpiPen.

Life-threatening allergic reactions can include reactions to insect bites or stings, foods, medications, latex, and other substances. Anaphylaxis is a medical emergency that occurs in roughly 1 in 50 Americans. The EpiPen automatically injects a dose of epinephrine into a person's thigh to stop an allergic reaction.

The most common side effects associated with epinephrine injection are anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea, vomiting, headache, and respiratory difficulties. Rare cases of serious skin and soft tissue infections have been reported following use of the drug.

In patients with heart disease, epinephrine injection may cause angina pectoris or ventricular arrhythmias. Following 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 for injection-site injury, movement of the leg should be limited during injection.

"Today's approval marks an important step forward in bringing patients an additional epinephrine autoinjector option and furthers our commitment to accessibility to quality products for the patients who need them," Teva's Brendan O'Grady said in a statement.

The company said it's applying its full resources to launch the product in the coming months.

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