BRIEF—FDA takes additional action to mitigate shortages of EpiPen

The US 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 USA.

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.

Last week, the FDA also approved the  first generic version of the EpiPen and EpiPen Jr (epinephrine) auto-injectors for the emergency treatment of allergic reactions, developed by Israeli generics giant Teva Pharmaceutical Industries.