In an attempt to mitigate an ongoing shortage of Epipen auto-injectors, the FDA today extended the expiration date of specific lots of 0.3-mg devices by four months.
The move to extend the expiration dates beyond the approved 20-month shelf-life is based on stability data provided by Mylan (NSDQ:MYL) to the FDA, the U.S. regulatory agency reported.
“Many patients rely on self-injectable epinephrine products, such as Epipen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children. We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation & Research, said in prepared remarks.
“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,” Woodcock added.
Mylan reportedly told the FDA months ago that delays experienced by its manufacturing partner, Pfizer’s Meridian Medical Technologies, were straining its Epipen supply.
Earlier this year, a survey from the advocacy group Food Allergy Research & Education found that hundreds of people across the U.S. have had trouble getting an Epipen.
Some patients reported waiting weeks to find the life-saving device, while others were unable to get an Epipen at all, according to a report from Bloomberg.
Several epinephrine auto-injector manufacturers have reported shortages, according to the U.S. regulatory agency’s website, including Impax Laboratories (NSDQ:IPXL), Mylan and Hospira.
The U.S. is not the only country facing an Epipen shortage; similar challenges have cropped up in Canada and the U.K. In Canada, the problem is especially dire, as there are no alternatives to Mylan’s Epipen on the market.
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