FDA Approves First Direct Generic Form of EpiPen

On Thursday, the Food and Drug Administration (FDA) approved the first direct generic competitor to EpiPen and EpiPen Jr. A generic version typically means a lower-cost alternative.

“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,” FDA commissioner Scott Gottlieb, M.D., said.

This epinephrine auto-injector, manufactured by Teva Pharmaceuticals, will be prescribed for serious allergic reactions such as anaphylaxis. The FDA approved it for use in adults and children weighing more than 33 pounds.

Dramatic price hikes and shortages have plagued the name-brand EpiPen, which is manufactured by Mylan. The FDA added EpiPens to its drug shortage list in the spring, and Mylan has come under fire for hiking its prices by over 400 percent. Mylan does have an “authorized generic” form of its EpiPen, which the FDA approved in 2016. The difference is authorized generics are exactly the same as the name-brand but without the label. Mylan made the authorized generic soon after the outrage about high EpiPen prices.

A generic drug, which is what the FDA approved today, is typically made by another pharmaceutical company and can have minor differences between the medications like inactive ingredients. Though Mylan has a lower-cost authorized generic form, a competitor like Teva can force pharmaceutical companies to further lower the drug prices.

Teva, however, has not yet said the cost of its product or when it will be released.

Related: Here’s What You Should Know If You Are Struggling to Afford Your EpiPen