FDA takes additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending expiration date for specific lots of medication – Drug Information Update

The U.S. Food and Drug Administration today 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. 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, 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. Mylan also has established a customer service number, which we have posted on the FDA's website, to help pharmacies and patients locate EpiPens if necessary. Information on supply information of other approved epinephrine autoinjector products can also be found on the agency’s website. For more information, please visit: EpiPen FDA In Brief. For extended use dates, please visit: Extended Use Dates Provided by Pfizer.