The Food and Drug Administration approved the first generic version of EpiPen on Thursday, Aug. 16, 2018, a move that will bring new competition for the lifesaving allergy injection that helped spark public furor over high drug prices.
Photo: Drew Angerer/Getty Images
Photo: Drew Angerer/Getty Images

FDA approves first generic EpiPen competitor

generic version of the life-saving allergy drug EpiPen was approved Thursday by the Food and Drug Administration. 

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The new drug, from Teva Pharmaceuticals USA, can now automatically be substituted at the pharmacy counter for EpiPen and EpiPen Jr. prescriptions, The Washington Post reported

This comes during back-to-school season, one of the busiest for EpiPen as parents stock up for school, according to NBC.

There has been “limited availability” of EpiPens across the United States, an FDA spokesperson told the Washington Post.

Teva has not stated when the drug will be released or how much it will cost. 

EpiPen, made by Mylan, is used to stop deadly allergic reactions to bee stings, peanuts and shellfish, among other potentially fatal allergens.

The main ingredient, epinephrine, is injected into the thigh.

The EpiPen combines the drug with a specialized device that delivers relief quickly from a life-threatening allergic reaction.

“Anaphylaxis occurs in approximately one in 50 Americans,” the FDA stated. “People who have had an anaphylaxis episode always face the risk of another one. Because of this risk, they must carry an emergency dose of epinephrine at all times. Many must keep more than one dose at hand.”

Since the drug was introduced on to the market in 1987, prices have risen consistently -- from less than $100 in 2007 for a two-pack, to over $600 in 2018. Since 2004, EpiPen costs have increased 450 percent, the Post reported.

Heather Bresch, Mylan’s CEO, was the subject of a contentious congressional hearing in 2016, where she was criticized for accepting an $18 million salary and for evading questions about how much profit the company made off the lifesaving treatment.

In response, EpiPen released a generic version of its product. EpiPen alternatives, sold by Mylan, are already on the market.

Adrenaclick offers a cheaper, generic version of the injector pen, but the alternatives still have slightly different designs and are not authorized copies of the EpiPen drug.

“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,” Scott Gottlieb, commissioner for the FDA, said in a statement.

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