FDA Approves First Generic Version Of The EpiPen. Here's Why That Matters.

Anaphylaxis occurs in approximately one in 50 Americans

On August 16, the Food and Drug Administration (FDA) announced that it has approved the first generic version of the EpiPen and EpiPen Jr., a smaller dose for kids. The generic version is made by Teva Pharmaceuticals USA and the company has been given approval to market its epinephrine auto-injector in 0.15 mg and 0.3 mg strengths.


The news is important to those who have life-threatening allergies because it makes affordable auto-injectors more accessible.

It's a key development at a time when there's an ongoing EpiPen shortage that's leaving many parents concerned for the upcoming school year. Fortune reports that the shortage has been caused by high demand coupled with manufacturing and supply chain issues. In fact, EpiPens were added to the FDA's drug shortage list in May, according to CNN.

Another issue is the rising price of the EpiPen. The New York Times reports that Mylan, the company who produces the EpiPen auto-injector, has raised the price of it sixfold since they purchased it in 2007. Before, a set of two injections would cost under $100. Now, they cost $600.

The FDA hopes that the approval of Teva Pharmaceuticals USA's auto-injector will be a positive change. "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," reported FDA Commissioner Scott Gottlieb, M.D. in a press release.

The FDA points out that anaphylaxis occurs in approximately one in 50 Americans so having affordable auto-injectors at hand is critical.

(H/T: BuzzFeed)

Cover image via Rob Byron I Shutterstock


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