August 21, 2018
In a move meant to help ease shortages of EpiPen (epinephrine) autoinjectors, the US Food and Drug Administration (FDA) has extended by 4 months the expiration date of specific lots of 0.3-mg products marketed by Mylan and the authorized generic version, manufactured by Meridian Medical Technologies.
This extension beyond the approved 20-month shelf life is based on stability data that the FDA reviewed, the agency said in a statement. A complete list of specific batch numbers with original and new expiration dates are provided on the FDA website.
"We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
"We've completed the necessary reviews of the data to extend the expiration date by 4 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," said Woodcock.
The FDA said multiple factors, including regional supply disruptions and problems in manufacturing, have contributed to EpiPen's limited availability in certain areas in the United States. The agency is continuing to work closely with Mylan on EpiPen production and supply, and is in close contact with the other manufacturers of epinephrine autoinjectors, including Adrenaclick and Auvi-Q, regarding their supply. The start of the school year is historically accompanied by increased product demand.
Mylan has established a customer service number to help pharmacies and patients locate EpiPens if necessary.
The FDA recently approved the first generic version of the EpiPen, as reported by Medscape Medical News.
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SOURCE: Medscape, August 21, 2018.