Since the article covering the epinephrine auto-injector shortage appeared in last month’s issue, there have been two notable developments related to these devices used to treat life-threatening allergic reactions (anaphylaxis):
On Aug. 16, the FDA approved the first generic version of Mylan’s EpiPen (0.3 mg strength) and EpiPen Jr. (0.15 mg strength) epinephrine auto-injector by Teva Pharmaceuticals for the emergency treatment of allergic reactions in adults and children who weigh more than 33 pounds. In the FDA announcement, FDA Commissioner Scott Gottlieb, M.D., said, “This approval means patients… should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.” Other FDA-approved epinephrine auto-injector products include EpiPen, Adrenaclick and Auvi-Q. In addition, “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names.
To mitigate shortages of EpiPen, the FDA announced on Aug. 21 that it is extending the expiration date by four months for specific lots of Mylan’s EpiPen 0.3 mg products (NDC 49502-102-02 or NDC 49502-500-02 appears on the box; NDC 49502-102-01 or 49502-500-01 appears on the individual device within the box). According to the FDA announcement, this change beyond the 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, regional supply disruptions and manufacturer issues have contributed to EpiPen’s limited availability in certain areas in the U.S.
For the latest information on epinephrine auto-injectors, including the list of batch numbers assigned new expiration dates, visit fda.gov.