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FDA OKs first generic EpiPen

August 17, 2018

Patients with allergies who need regular access to epinephrine may have a more affordable option.

The U.S. Food and Drug Administration announced Aug. 16 that it approved the first generic versions of the EpiPen and EpiPen Jr auto-injectors to treat allergic reactions. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths, which are equivalent to the EpiPen brands, according to a news release.

EpiPen maker Mylan has faced criticism in recent years for its prices, charging some patients hundreds of dollars for a two-pack.

“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,” said FDA Commissioner Scott Gottlieb, M.D., in a news release.

The EpiPen automatically injects a dose of epinephrine into a person’s thigh to stop an allergic reaction.

In a statement on its website, Teva Pharmaceuticals said “the company is applying its full resources to this important launch in the coming months.”