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FDA Approves First Generic Version of the EpiPen

Long subject to rising prices and shortages, the singular EpiPen will now be forced to compete with a generic alternative.

Posted: Aug 16, 2018 2:18 PM
Updated: Aug 16, 2018 2:27 PM

WASHINGTON, D.C. — In a process that has been several years in the making, the U.S. Food & Drug Administration announced on Thursday that they have approved the first generic version of the EpiPen, the once-singular epinephrine injector that has proven invaluable in preventing severe allergic reactions for many.

The Epi-Pen, though near-ubiquitous, has been subject to price increases and shortages that have alarmed and angered many users who rely upon the product.

“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. “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."

Oregon Representative Greg Walden (R-Hood River) praised the approval of a generic alternative in a statement on Thursday:

"Patients are tired of the sharp increases in prices for drugs and devices," said Walden. "For families across the country, the EpiPen is a lifesaving drug, but it comes at a cost. This generic alternative is a welcome move."

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