FDA News

FDA extends EpiPen expiration date to mitigate shortages

The FDA is taking steps to alleviate EpiPen shortages by extending the expiration date of certain lots of 0.3 mg products by 4 months.

“Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We are doing everything we can to help mitigate shortages of these products... We’re hopeful this action will ensure patients have access to this important medication.”

The FDA approved the extended shelf life of EpiPen by reviewing stability data from Mylan, EpiPen’s manufacturer. EpiPens that have already been prescribed to patients should continue to be stored as labeled to ensure safety, according to FDA.

A study published in Annals of Internal Medicine last year found that EpiPens remain effective well beyond their expiration date.

The limited availability of EpiPens has been caused by regional supply disruptions and manufacturer issues, according to FDA.

The FDA also recently approved the first generic version of EpiPen.

Disclosure: Woodcock is an employee of the FDA.

The FDA is taking steps to alleviate EpiPen shortages by extending the expiration date of certain lots of 0.3 mg products by 4 months.

“Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We are doing everything we can to help mitigate shortages of these products... We’re hopeful this action will ensure patients have access to this important medication.”

The FDA approved the extended shelf life of EpiPen by reviewing stability data from Mylan, EpiPen’s manufacturer. EpiPens that have already been prescribed to patients should continue to be stored as labeled to ensure safety, according to FDA.

A study published in Annals of Internal Medicine last year found that EpiPens remain effective well beyond their expiration date.

The limited availability of EpiPens has been caused by regional supply disruptions and manufacturer issues, according to FDA.

The FDA also recently approved the first generic version of EpiPen.

Disclosure: Woodcock is an employee of the FDA.