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FDA Extends Expiration Dates for EpiPens by Four Months

Posted 21 August 2018 | By Zachary Brennan 

FDA Extends Expiration Dates for EpiPens by Four Months

With a shortage of the life-saving EpiPens persisting, the US Food and Drug Administration (FDA) on Tuesday extended specific lots' expiration dates by four months.

FDA said the extensions are for 0.3 milligram products marketed by Mylan.

“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, director of FDA’s Center for Drug Evaluation and Research.

FDA alerted health care professionals and patients of updated dates by which some EpiPens and the authorized generic version, manufactured by Pfizer’s Meridian Medical Technologies, may be used beyond the manufacturer’s labeled expiration date.

The decision to extend certain expiration dates follows the approval of the first generic version of the EpiPen last week. In addition to the US, Canada is also experiencing a shortage of EpiPens.

“This change beyond the approved 20-month shelf life is based on stability data provided by Mylan and reviewed by the FDA,” FDA said. “Patients that have the batch numbers below will be able to use them through the corresponding new use dates to help with supply. As data become available, this list can continue to expand.”

FDA noted that if replacement product becomes available during the extension period, then the agency expects the lots in these tables in the link below “will be replaced and properly disposed of as soon as possible.”

Extended Use Dates Provided by Pfizer

Categories: Regulatory News

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