FDA gives expiring allergy shots new life span

Pittsburgh Post-Gazette

The U.S. Food and Drug Administration extended the expiration date by four months on some lots of Mylan’s EpiPen emergency allergy shot Tuesday in an effort to alleviate shortages heading into the school year.

The federal agency made the decision after analyzing data provided by Mylan regarding the stability of the product.

EpiPens have an approved shelf life of 20 months. The decision applies to specific lots of EpiPens with 0.3 milligram doses of epinephrine, which can be used for four months beyond the expiration date on the label, the FDA said. The agency said the devices covered by the extension have either already expiredor are close to expiring.

“We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation andResearch, said in a statement.

Pfizer makes the injectors for Mylan and has had manufacturing problems. Those issues prompted the FDA in May to add the EpiPen to its list of drugs in short supply.

Last week, the FDA approved a genericversion of the product made by Israel’s Teva Pharmaceutical Industries. Teva is the first drugmaker to launch a generic alternative to the EpiPen, but the company did not say when the product will hit drugstore shelves. Nor did it say howmuch it will cost.

Other companies, including Adrenaclick and Auvi-Q, make epinephrine injectors. Mylan launched its own generic version of the EpiPen in late 2016 after enduring harsh criticism for hiking the price on the lifesaving product by about 500 percent.

The FDA said it has posted Mylan’s customer service number on its website, as well as information about alternative products.

Mylan has its operations base in Cecil.