FDA approves generic EpiPen

epipen-photoStaff photo

A generic version of the life-saving EpiPen has been approved by the Food and Drug Administration.

The EpiPen is used to counteract severe allergic reactions that can be caused by things such as insect stings, foods and medications. It injects a dose of epinephrine into the victim’s thigh and acts quickly to reduce airway swelling and to increase blood flow in the veins. People who have had an anaphylaxis episode always face the risk of another one. Because of that they must carry an emergency dose of epinephrine at all times. Many keep more than one dose at hand.

The price for a pair of EpiPens runs around $600. That price has risen from less than $100 ten years ago, putting it out of the range for some users and creating a wave of criticism for Mylan, its manufacturer.

The generic version is made by Teva Pharmaceuticals and will be available in both the 0.3 mg and the 0.15 mg strengths. The approval of the generic version covers both the EpiPen and the EpiPen Junior, which is used for children. The price of the generic hasn’t yet been released.

“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 FDA Commissioner Scott Gottlieb, M.D. 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.”

A Teva spokeswoman told the Wall Street Journal “We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market,” but it’s not known when it will be available at pharmacies.



About the Author

Ed Tobias
Ed Tobias brings more than four decades of reporting and news management experience to his work at Rx411. Tobias managed news coverage for Associated Press Radio for over twenty years. This included coverage of the 9/11 attacks, the Iraq War, Hurricane Katrina, the death of Princess Diana, the Challenger and Columbia shuttle disasters and national election primaries, conventions and campaigns. He was part of the team that built AP’s on-line video operation. Prior to joining AP, Tobias was News Director at all-news WTOP in Washington, D.C.