FDA Adds 4 Months To Expiration Date On EpiPens In Face Of Shortage
The Food and Drug Administration is working with Pfizer to extend the expiration date on certain lots of Mylan's EpiPen 0.3 milligram injectors by an additional four months. The move is made because of an ongoing shortage of the lifesaving drug.
Reuters:
FDA Extends EpiPen Expiry Date To Combat Shortage
The U.S. Food and Drug Administration on Tuesday extended the expiration date of specific lots of Mylan NV’s EpiPen allergy injectors by four months to mitigate the shortage of the life-saving treatment. The decision comes at a time when the shortage has come under focus at the start of back-to-school season, and applies to specific lots of 0.3 milligram EpiPen products, after the regulator reviewed data provided by Mylan. (8/21)
The Hill:
Pfizer Extends Some EpiPen Expiration Dates Amid Nationwide Shortage
Pfizer will extend by four months expiration dates of EpiPen 0.3 milligram Auto-Injectors and its authorized generic. "Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth-quarter of 2018," Pfizer said in a statement Tuesday. (Hellmann, 8/21)
CNBC:
EpiPen Shortage: FDA Extends Some Expiration Dates To Help
The extension doesn't apply to EpiPen Jr., which is used for kids weighing between 33 pounds and 66 pounds and provides half the dose of epinephrine. EpiPens typically have a shelf life of 20 months, according to the FDA, which said it's allowing the additional four months after reviewing stability data provided by Mylan. The move comes as parents of children with allergies are finding EpiPens hard to come by in pharmacies as they stock up for back-to-school season. (Tirrell, 8/21)
Miami Herald:
FDA Extends Expiration Dates On EpiPens, Generic Versions
The decision to extend the expiration for some batches of the EpiPen is based on a review of product stability data, Pfizer said. There has been a nationwide shortage of epinephrine injection devices since February. (Neal, 8/21)
