FDA extending expiration dates for some EpiPens

Tuesday, August 21, 2018

The U.S. Food and Drug Administration announced it's extending the expiration date for some EpiPens.

EpiPens are auto-injectors that deliver epinephrine to help treat life-threatening allergic reactions.

The expiration date extensions come in the wake of an ongoing shortage of EpiPens.

They were added to the FDA's drug shortage list in May.

According to the pharmaceutical company Pfizer, the extension applies to specific lots of EpiPen 0.3-milligram auto-injectors and the authorized generic version that have expiration dates between April 2018 and December 2018.

"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 and Research said in a written statement. "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."

The FDA announced last week it has approved the first generic version of EpiPen which will be available in the coming months.