RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 8 > FDA Approves First Generic Versions of EpiPen

FDA Approves First Generic Versions of EpiPen

Posted 16 August 2018 | By Zachary Brennan 

FDA Approves First Generic Versions of EpiPen

The US Food and Drug Administration 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 (anaphylaxis) in adults and children weighing more than 33 pounds.

The approval comes as the US has grappled with shortages of EpiPens and following delays. The approval means Teva can market its generic, substitutable epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

Teva said in a statment: "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.

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.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.