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FDA approves new generic version of the EpiPen for allergic reactions

17 August 2018

The new drug, from Teva Pharmaceuticals USA, is the first to be deemed a therapeutic equivalent of the EpiPen, which means that it can be automatically substituted at the pharmacy counter for prescriptions for EpiPen or EpiPen Jr. Consumers and lawmakers have been clamoring for a generic version of the EpiPen ever since its manufacturer, Mylan, drastically hiked the price more than 400 percent in less than a decade.

Teva spokeswoman Doris Saltkill said the price of the drug and the exact launch date were not yet available, but the company's statement suggested it would not be in time for many parents who are scrambling to find EpiPen in their pharmacies now.

In 2009, Mylan had Teva sued for patent infringement, leading to a settlement that kept Teva off the EpiPen market until 2015.

FILE - Mylan CEO Heather Bresch testifies, September 16, 2016, before Congress over the cost of her company's EpiPens. "Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the 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 in a statement announcing the approval.

Yet "the path to developing generic drug-device combination products like this one is challenging", Gottlieb said, because combination drugs consist of two parts: the drug, such as epinephrine, and the device, such as the auto-injector.

The soaring cost of brand name EpiPens, from drug maker Mylan, has led to uproar over the years.

Mylan has also been facing supply issues.

Mylan introduced its own half-priced generic version of the drug in 2016.

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The decision is a long-awaited victory for Teva, which has been trying to bring a generic EpiPen to the market for years.

There are two other brand products on the market for severe allergic reaction: Adrenaclick and Auvi-Q.

Teva's long-sought generic now offers patients that option-and the potential for lower prices.

But now the new generic from Teva Pharmaceuticals could drive the prices down even more.

Teva added, "We will allocate maximum resources in the coming months and expect to bring this product to market".

Since acquiring the rights to EpiPen in 2007, when a dose cost about $57, Mylan sparked public furor two years ago by hiking the cost of EpiPen to $600 for a two-pack of the auto-injecting pens.

Teva did not respond to questions about how much its generic version will cost, or when it will become available.

FDA approves new generic version of the EpiPen for allergic reactions