This date modification beyond the approved 20-month shelf life was based on an FDA review of product stability data submitted by Mylan. Several factors contributed to the product’s limited availability in certain areas of the US, including regional supply disruptions and manufacturer issues. Specifically, Mylan cited intermittent supply constraints due to manufacturing delays from their partner, Meridian Medical Technologies, a subsidiary of Pfizer. Continual supply from Meridian is still ongoing and Mylan is expediting shipment to wholesalers upon receipt. Meridian also manufactures EpiPen Jr 0.15mg Auto-Injectors and the authorized generic versions of these strengths.
The full list of EpiPen Auto-Injectors and Epinephrine Injection, USP Auto-Injectors 0.3mg with extended expiration dates can be found here. Patients with product from these batch numbers will be able to use them through the new use dates provided.
“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, MD, director of the FDA’s Center for Drug Evaluation and Research.
For more information call (800) 796-9526 or visit FDA.gov.