FDA Approves First Generic Epinephrine Auto-Injector

Author(s):

Kristen Coppock, MA, Editor

The FDA has approved the first generic epinephrine auto-injector for the emergency treatment of allergic reactions, including anaphylaxis.

This article originally appeared on Pharmacy Times.

The FDA has approved the first generic epinephrine auto-injector for the emergency treatment of allergic reactions, including anaphylaxis. Teva Pharmaceuticals' approved product, 0.3 mg and 0.15 mg strengths generic versions of EpiPen and EpiPen Jr, is indicated for adults and pediatric patients who weigh more than 33 pounds.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe, and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.

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. Anaphylaxis occurs in approximately 1 in 50 Americans. Patients who have had an anaphylaxis episode always face the risk of another one. Because of this risk, they must carry an emergency dose of epinephrine at all times. Many must keep more than one dose at hand.

In a statement to

Pharmacy Times

, Lisa Gable, CEO of Food Allergy Research & Education (FARE), a national advocacy organization, applauded the FDA's decision to approve Teva Pharmaceuticals' generic product. “For far too long, families managing food allergies have struggled to afford epinephrine auto-injectors, or even to fill their prescriptions given the current national shortage," Gable said in the statement. "Food Allergy Research & Education has long called for increased competition in the marketplace to improve affordability."

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