FDA Extends EpiPen Expiration Dates

EpiPen

The good news continues for those who rely on EpiPens! The FDA has extended the expiration date of some EpiPens due to shortages. As the school year begins the demand for this life-saving drug has continued to rise. After manufacturing delays and supply disruptions, pharmacies have been struggling to keep EpiPens in stock.

How is the Expiration Date Changing?

The FDA has received “stability data” from Pfizer, a manufacturer of EpiPens, and conducted its own review to conclude the devices are effective beyond the expiration dates set by the manufacturers. This expiration date extension will only apply to specific lots of EpiPen that are expired or close to expiring. Specific batches of 0.3 milligram products manufactured by Mylan may be used for four months beyond their expiration dates. If you have any concerns regarding the usability of your EpiPen, contact your dispensing pharmacy.

Have any Questions for us?

Contact the Tria Health Help Desk at 1.888.799.8742

FDA Approves First Generic Version of EpiPen

EpiPen

On Thursday, The FDA approved the first generic version of EpiPen. EpiPens are designed to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction. The generic is made by Teva Pharmaceuticals and will compete against Mylan. Teva has not disclosed the price or release date at this time.

Background

Since purchasing EpiPen in 2007, Mylan has drastically raised the price of EpiPen. Mylan has also had many issues with shortages and issues with their manufacturer. The FDA issued a warning to Mylan’s manufacturer Pfizer after multiple cases of EpiPen malfunctions.

Are there other EpiPen Generics?

In 2016, Mylan released its own generic version of the EpiPen that was roughly half the cost of the original price. The brand name medication can cost as much as $600 for a package of two pens. Teva’s EpiPen is the first from a competitor that is a true “therapeutic equivalent” according to the FDA. This will be the first product that can be easily substituted for customers by their pharmacists.

Have any Questions for us?

Contact the Tria Health Help Desk at 1.888.799.8742