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U.S. Approves New Generic Competitor to EpiPen

A launch within months is planned, but no word on the price

Epipen 2 pak needles

Joe Raedle/Getty Images News/Getty Images

U.S. health officials this week approved a new generic version of EpiPen, the emergency allergy medication that triggered a public backlash due to its rising price tag.

The version from Teva Pharmaceuticals is the first that will be interchangeable with the original penlike injector sold by Mylan. The Food and Drug Administration announced the approval in a statement.

EpiPen injections are stocked by schools and parents nationwide to treat children with severe allergies, and many Medicare patients rely on them. They are used in emergencies to stop potentially fatal allergic reactions to insect bites and stings and to foods such as nuts and eggs.

Generic drugs can be priced as much as 80 percent lower than the original product. But those price cuts usually appear after several companies have launched competing versions.

EpiPen maker Mylan has dominated the $1 billion market for the shots for two decades. Several other companies sell competing shots containing the drug epinephrine, but they aren't heavily marketed or prescribed by doctors.

In 2016, Congress blasted Mylan in letters and hearings for raising the EpiPen price for a two-pack to $600, a five-fold increase over nearly a decade. The company responded by launching its own lower-cost generic version for $300.

Mylan continues to sell both versions at those prices, according to data from Elsevier's Gold Standard Drug Database.

Teva's generic shot will be the first version that pharmacists can substitute even when doctors prescribe the original EpiPen.

A Teva spokeswoman declined to comment on the drug's price but said it would launch “in the coming months."

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