First Generic EpiPen Approved by FDA

The U.S. Food and Drug Administration has approved the first generic alternative to the EpiPen and EpiPen Jr (epinephrine) auto-injector, which is used for the emergency treatment of allergic reactions, including those that are life-threatening, in adults and children.

The approval of a generic alternative to the EpiPen and EpiPen Jr., made by Teva Pharmaceuticals USA, comes on the heels of a major EpiPen shortage that has left parents of school-age children scrambling to find them as the school year begins, and which has resulted in the FDA extending EpiPen expiration dates. The FDA came to this decision after Mylan, the manufacturers of the EpiPen, requested the extension, and provided data to show that it would be safe to use them past their 20-month listed shelf life.

This approval was described as, “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,” by FDA Commissioner Scott Gottlieb, M.D.

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