EpiPen expiration dates extended to combat worsening shortage

To combat the worsening EpiPen shortage, the FDA is extending the expiration date of some lots of EpiPen and its authorized generic by four months.

Here are five things to know:

1. The shelf-life extension applies to the 0.3 milligram doses of EpiPen and its generic with current expiration dates between April and December 2018.

2. The extension doesn't apply to EpiPen Jr., which is used in children weighing 33 to 66 pounds.

3. The announcement was made by the FDA and Pfizer, the drugmaker that manufactures EpiPen for Mylan.

4. EpiPen's have a typical shelf-life of 18 to 20 months. The FDA is allowing an additional four months after reviewing stability data.

5. The decision by the FDA to allow an extended shelf life comes at an optimal time. During the back-to-school push, sales of EpiPen spike as parents stock up for school. In recent months, patients and pharmacists in 45 states reported difficulty finding EpiPens, leading the FDA to issue a supply shortage alert.

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars