- The Food and Drug Administration has extended the expiration date for certain lots of Mylan's EpiPen, an attempt to offset current shortages stemming from a variety of supply and manufacturing issues.
- The extension of four months beyond the approved 20-month shelf life is based on reviews of the data for specific lots of Mylan's epinephrine auto-injector that are expired or close to expiring.
- The FDA is also working with manufacturers of epinephrine auto-injectors, including Kaléo's Auvi-Q and Impax Pharmaceuticals' Adrenaclick. Adamis Pharmaceuticals also has approval for a prefilled epinephrine syringe, known as Symjepi.
Supply issues for Mylan's EpiPen and its authorized generic drag on, resulting from manufacturing issues at Pfizer's subsidiary, Meridian Medical Technologies. While Mylan and Pfizer have said they are exploring options "that would help stabilize supply," the FDA has stepped in, in an attempt to head off a shortage before the beginning of the U.S. school year. This is traditionally a period of high demand for the product.
"Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children. We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season," said Janet Woodcock, director of the agency's Center for Drug Evaluation and Research in an FDA in Brief note.
“The FDA remains committed to using all of the tools available to help prevent and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition,” Woodcock added.
Impax Laboratories' Adrenaclick, which the FDA has suggested as an alternative, is currently undergoing its own supply challenges. It is listed on the FDA Drug Shortages website as "Currently in Shortage" as of May 2018, following the finding of particles in certain lots. Any affected auto-injectors should be returned to a pharmacy.
Kaléo is touting its Auvi-Q to fill the gap for the back-to-school season, with a cash price of $360, or $0 for families with incomes of less than $100,000, but the product has a wholesale acquisition cost (WAC) of $4,900. Another company poised to step into the market, though it hasn't yet revealed a price, is Teva Pharmaceuticals. Teva's EpiPen generic was approved by the FDA last week.
To add to Mylan and Pfizer's difficulties, a class action lawsuit claiming that the two companies violated antitrust and racketeering laws while managing the EpiPen injector franchise has been allowed to continue.