FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication

FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication

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. Continue reading...