FDA adds EpiPens to drug shortage list

May 11, 2018

The U.S. FDA added EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors as well as the authorized generic versions to its drug shortages list, citing issues relating to good manufacturing practices.

FDA spokeswoman Lauren Smith Dyer said the agency anticipates the EpiPen shortage to be short-term.

While Mylan confirmed that there are "intermittent supply constraints," the drugmaker noted that product is available and that they are currently receiving continual supply from manufacturing partner Meridian Medical Technologies, a Pfizer company. Pfizer manufactures both the branded and authorized generic versions of EpiPen, and Mylan is the distributor.

Mylan’s manufacturing issues date back to a warning letter  sent to Meridian Medical's Missouri manufacturing facility last fall, when the agency said Pfizer failed to properly investigate more than 100 complaints that the device malfunctioned.

Meanwhile, Mylan encourages patients who are experiencing difficulty accessing product to contact the company's customer relations department.

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