Generic EpiPen approved in time for device shortage | Innovation

The first generic version the has been by the FDA.

Teva Pharmaceuticals’ generic version of the epinephrine auto-injector has been approved by the FDA in a push from the organisation to approve more generic products.

The generic version will act as a replacement for brand name versions by device maker Mylan, which came into controversy in 2016 when it raised the price of its EpiPens from $56 per pen to $317.  

The approval also follows a shortage of EpiPens within the US market caused by delays from manufacturers. Teva’s generic now means the market has a substitutable epinephrine auto-injector across two different strengths.

EpiPen autoinjectors are used to treat people who can suffer from severe allergic reactions and are potentially life-saving devices.

There are other version of epinephrine auto-injectors but Teva’s is the first device to be considered a generic to the branded EpiPen.

Speaking about the approval, Teva said in a statement: “We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market.”

FDA Commissioner Scott Gottlieb said: “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.”

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