How the FDA Is Fighting the Nationwide EpiPen Shortage

Health and Healthcare

Published: August 21, 2018 1:05 pm

Last Updated: January 11, 2020 7:02 pm

Epinephrine autoinjectors, particularly Mylan N.V.’s (NYSE: MYL) EpiPens, have been in the limelight over the past couple of weeks, whether it’s the discussion about the shortage or that a new competitor has entered the generic EpiPen arena. However, U.S. Food And Drug Administration (FDA) is jumping into the fray again and extending the expiration dates for certain EpiPens in light of the national shortage.

According to a statement by Pfizer Inc. (NYSE: PFE), the FDA is extending the expiration date for the 0.3 mg dose of EpiPen and its generic version (with current expiration dates between April and December 2018) by four months.

Note that the extension doesn’t apply to EpiPen Jr., which is used for kids weighing between 33 and 66 pounds and provides half the dose of epinephrine.

Normally, EpiPens have a shelf life of 20 months, according to the FDA. The additional four months are in response to the stability data from Mylan.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, commented:

We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season. 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.

24/7 Wall St. had previously reported that Teva Pharmaceutical Ltd. (NYSE: TEVA) is entering the generic EpiPen business, and this could potentially lead to a price war with Mylan.

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