FDA addresses EpiPen shortage by extending expiration dates
August 22, 2018
The U.S. Food and Drug Administration announced Aug. 21 it is extending the expiration dates by four months of some EpiPens.
The announcement comes as some areas of the U.S. face shortages of the EpiPen, which injects a dose of epinephrine into a person's thigh to stop an allergic reaction. As families prepare for a new school year, the shortage has caused concern among some families, according to news reports.
"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, M.D., director of the FDA's Center for Drug Evaluation and Research, in a news release.
The expiration date extension — which goes beyond the approved 20-month shelf life — "is based on stability data provided by Mylan," the maker of EpiPen, according to the FDA. The extension applies to specific lots of .3 milligram EpiPens.
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Dentists can look for shortage notices, safety alerts and product recalls on the ADA Safety Alerts website by visiting ADA.org/SafetyAlerts