FDA Extends Expiry Date of Branded and Generic EpiPens Amid Ongoing Shortage

in Food Allergy, Food Allergy News
Published: August 21, 2018

The FDA is extending expiration of specific lots of Mylan’s EpiPen 0.3 mg and its authorized generic auto-injectors beyond the manufacturer’s labeled expiry date. This comes amid a national shortage that began in late April.

“This announcement is based on a careful review of product stability data provided by Pfizer,” according to a statement released Aug. 21 by Pfizer Inc., the manufacturer.

For the EpiPen regular dose and generic equivalent, “patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth-quarter of 2018,” said the statement.

However, the announcement does not apply to EpiPen Jr 0.15 mg and the equivalent generic of the device because “the data for the 0.15 mg does not support extension beyond current expiration dates,” Steve Danehy, Pfizer Inc.’s director of media relations, told Allergic Living.

The findings on the regular dose auto-injectors are in keeping with a 2017 University of California study, which found that epinephrine in a majority of EpiPens was viable after expiration, most commonly up to 29 months past the expiration date. A 2015 study had also found that epinephrine was often still viable in EpiPens two years after expiration.

Pfizer manufactures the EpiPen and generic auto-injector equivalent that Mylan distributes in the United States.

In Canada, the country’s health regulator says it’s working with Pfizer Canada and reviewing the FDA’s decision to extend the expiry dates of specific lots. A decision in Canada will be made “once we review the data that formed the basis of the FDA decision,” a Health Canada spokesperson told Allergic Living.

Download Pfizer’s statement here.