The decision extends the approved 20-month shelf life of Mylan’s EpiPen (epinephrine) auto-injector by four months beyond the labelled expiration date. The affected lots have current expiration dates between April and December 2018.
Pfizer, which is coordinating with the US Food and Drug Administration (FDA) on the expiration date extensions, said the decision is based on a review of stability data.
“Patients should have confidence in using the products from these particular lots as Pfizer works to stabilise supply, which is anticipated in the fourth-quarter of 2018,” the firm said in a statement.
“We believe the extension of the expiration date will temporarily address patients’ access to and use of EpiPen 0.3 mg Auto-Injectors, and the authorised generic, particularly during back-to-school season as demand increases.
“Pfizer is working tirelessly to increase production and expedite shipments as rapidly as possible,” the firm added.
Manufacturing concerns
According to Pfizer, undisclosed manufacturing issues are behind the supply shortage.
“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 US,” confirmed director of the FDA’s centre for drug evaluation and research, Janet Woodcock, in a statement yesterday.
“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,” she added.
The Agency has contacted other manufacturers of epinephrine auto-injectors, including Adrenaclick and Auvi-Q, regarding their supply.
The expiry extension comes days after the FDA approved the first generic version of Mylan’s EpiPen product. Marketing authorisation holder Teva did not respond to a request for comment ahead of publication.