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FDA approves generic epinephrine auto-injectors :

August 16, 2018

Children with severe allergies soon will have access to a new generic version of EpiPen and EpiPen Jr. epinephrine auto-injectors.

The Food and Drug Administration (FDA) granted approval to Teva Pharmaceutical Industries Ltd. to market the generics in 0.3 milligram (mg) and 0.15 mg strengths.

“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,” FDA Commissioner Scott Gottlieb, M.D., said in a news release. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.”

The Academy recommends children with serious allergies always keep two epinephrine auto-injectors with them and that they have a supply both at home and school.

However, EpiPen distributor Mylan has come under fire in recent years for charging some families hundreds of dollars for a package of two auto-injectors and has since introduced its own generic version. There also have been intermittent supply shortages for the past several months.

The generic versions will be made with the same formulation and strength as EpiPen, according to the FDA. Teva Pharmaceuticals said the generic epinephrine auto-injectors would launch “in the coming months.”

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