First Generic Version of EpiPen Gets FDA Approval

Epinephrine auto-injectors are used in the emergency treatment of allergic reactions
Epinephrine auto-injectors are used in the emergency treatment of allergic reactions

The Food and Drug Administration (FDA) has approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions (Type I) including anaphylaxis. Teva Pharmaceuticals will market the generic epinephrine auto-injectors in 0.15mg and 0.3mg strengths.

Recently, Mylan, the manufacturer of EpiPen, released a statement reporting continued supply issues due to interruptions in production of their epinephrine auto-injectors. In December of 2016, Mylan launched an “authorized generic” version of EpiPen, but as the product is manufactured using the same formulation, process, and facilities as the brand, it is subject to the same delays; authorized generics are made under a brand's existing new drug application.

“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, MD. “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.”

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Unlike other generic approvals, epinephrine auto-injectors are considered “combination products” because they consist of both a drug and a device, making the approval process more challenging. “These products can be hard to copy, and therefore sometimes don't face timely generic competition once patents and exclusivities are no longer a block to approval,” said Gottlieb, adding that the Agency is continuously working on ways to help guide manufacturers through the process to support the development of generic versions of these complex products.

In a press statement, Teva announced that “the company is applying its full resources to this important launch in the coming months and is eager to begin supplying the market.”

For more information visit FDA.gov.