FDA, New Products

After a years-long delay, FDA approves first generic versions of EpiPen

The FDA on Thursday approved Teva Pharmaceuticals’ first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening  in adults and children weighing more than 33 pounds.

The approval comes as the US has grappled with shortages of EpiPens following regulatory delays in getting a generic on the market. In the last decade, the price of EpiPens have shot up more than 400%. This new approval means Teva can market its generic, substitute epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

Teva said in a statement: “We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market.”

FDA commissioner Scott Gottlieb said the approval is part of a wider push to approve generic combination products like the EpiPen. “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,” said Gottlieb.

Teva $TEVA rose over 7% on the news.

FDA previously approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. In addition, “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names.


With additional reporting from Endpoints News. Image: Shutterstock

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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