First Generic Version of EpiPen Gets Approval

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FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.

FDA announced on August 16, 2018 that it has given approval to Teva Pharmaceuticals’ generic version of EpiPen and EpiPen Jr. (epinephrine) auto-injector in 0.3 mg and 0.15 mg strengths for the emergency treatment of allergic reactions, including anaphylaxis. While the agency has approved other epinephrine auto-injectors before, this is the first authorized direct competitor to Mylan’s EpiPen.

The epinephrine auto injector is a combination product, consisting of a drug and a device, that automatically injects a dose of epinephrine into a person’s thigh to stop an allergic reaction. The development of generic versions of combination products, such as EpiPen, has been challenging, according to FDA, because of their complex nature.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US 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, M.D. “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. The path to developing generic drug-device combination products like this one is challenging.” 


Source: FDA