(Reuters) – The U.S. Food and Drug Administration on Tuesday extended the expiration date of specific lots of Mylan NV’s EpiPen allergy injectors by four months to mitigate the shortage of the life-saving treatment.
FILE PHOTO: EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, DC, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo
The decisihere comes at a time when the shortage has come under focus at the start of back-to-school season, and applies to specific lots of 0.3 milligram EpiPen products, after the regulator reviewed data provided by Mylan.
Earlier this month, Mylan issued a warning that the devices may not always be available. The shortage has largely been due to ongoing manufacturing issues at a Pfizer plant which supplies EpiPens.
EpiPen autoinjectors allow the patient or a caretaker to administer a dose of epinephrine in case of a severe allergic reaction, such as to bee stings or exposure to peanuts.
Last week, the FDA approved Teva Pharmaceuticals’ generic version of Mylan’s drug.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shailesh Kuber