FDA Takes Action to Address Epipen Shortages

The U.S. Food and Drug Administration (FDA) took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3 milligram products marketed by Mylan by four months beyond the labeled expiration date. This change beyond the approved 20-month shelf life is based on stability data provided by Mylan and reviewed by the FDA. To help ensure patient safety, these products, which already have been dispensed to patients, should have been — and should continue to be — stored as labeled.

"Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children. We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season. We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring. We’re hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "The FDA remains committed to using all of the tools available to help prevent and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition."

While product is currently available, multiple factors, including regional supply disruptions and manufacturer issues, have contributed to EpiPen’s limited availability in certain areas in the U.S. The FDA continues to work closely with Mylan on EpiPen production and supply, and also has been in contact with the other manufacturers of epinephrine auto-injectors, including Adrenaclick and Auvi-Q, regarding their supply as the school year begins since this is historically accompanied by increased product demand. The agency also recently approved the first generic version of EpiPen.

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