Generic EpiPen Version Approved By FDA

The Food and Drug Administration has approved the first generic version of the EpiPen, the device used to treat severe allergic reactions including anaphylaxis, which can be life-threatening.

Teva Pharmaceuticals USA gained the FDA's approval to market a generic EpiPen and EpiPen Jr., the agency said on Thursday. FDA Commissioner Scott Gottlieb said in a statement that the approval means people living with severe allergies should have a lower cost option as well as another approved product to help protect against potential drug shortages.

The Food and Drug Administration's action Thursday opens the door to more competition for a drug that has faced public outrage over its price tag. The injections are stocked by schools and parents to treat allergic reactions to food and bug bites.

Mylan, the manufacturer of the EpiPen that has dominated the market, began offering a generic version of the epinephrine auto-injector in 2016 after outrage over how much the company had raised the price of the drug over nearly a decade. Mylan's brand name two-pack EpiPen costs $609 and the company's generic version is priced at half the cost. Adrenaclick, another epinephrine auto-injector, has a generic version that retails for $109.

According to the FDA, anaphylaxis occurs in approximately one in 50 Americans. The EpiPen injects a dose of epinephrine into a person's thigh to stop an allergic reaction.

A spokeswoman for Teva told The Washington Post that the price of the new generic drug and its exact price were not yet available.

Reporting from The Associated Press was used in this report.

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