FDA approves first generic version of EpiPen

The Food and Drug Administration approved the first generic version of EpiPen on Thursday, a move that will bring new competition for the lifesaving allergy injection that helped spark public furor over high drug prices.

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.

The approval comes right before the back-to-school season, when sales of EpiPen typically spike as parents stock up on injectors for school or replace expired ones, and people have reported difficulty filling EpiPen prescriptions. There has been “limited availability of EpiPen in certain areas in the U.S., including both pharmacy-level supply disruptions and a manufacturer issue,” according to FDA spokeswoman Theresa Eisenman.

The EpiPen, made by Mylan, is used to inject the hormone epinephrine into the thigh to quell potentially fatal reactions to bee stings, peanuts and other allergens. Although the key ingredient is cheap and the EpiPen itself was first approved in 1987, Mylan began increasing the price of the product, from less than $100 in 2007 for a pack of two injectors to $608 today. In response to criticism over the price of its drug, EpiPen introduced its own half-priced generic in 2016.

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