FDA Takes Action to Mitigate Shortages of EpiPenBy
The US Food and Drug Administration (FDA) is taking action to mitigate shortages of Mylan’s EpiPen (epinephrine), an auto-injector-based epinephrine product for treating adverse allergic reactions, by extending the expiration date of specific lots of 0.3-milligram products marketed by Mylan by four months beyond the labeled expiration date. This change beyond the approved 20-month shelf life is based on stability data provided by Mylan and reviewed by the FDA.
Mylan reported earlier this month (August 2018) that its manufacturing partner, Meridian Medical Technologies, a Pfizer company, continues to experience interruptions in the production of EpiPen 0.3-mg and EpiPen Jr 0.15-mg auto-injectors. “Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies,” said Mylan in an August 8, 2018 release. “We are actively exploring several options with Pfizer that would help stabilize supply. We will continue to provide updates, including timing for resolution, as we receive them from Pfizer.”
Multiple factors, including regional supply disruptions and manufacturer issues, have contributed to EpiPen’s limited availability in certain areas in the US, according to information from the FDA. The FDA says it continues to work with Mylan on EpiPen production and supply and says it also has been in contact with the other manufacturers of epinephrine auto-injectors regarding their supply as the school year begins since this is historically accompanied by increased product demand.
These manufacturers and products include Auvi-Q (epinephrine injection, USP) by Kaléo, a Richmond, Virginia-based pharmaceutical company, and Adrenaclick (epinephrine injection, USP auto-injector) by Amedra Pharmaceuticals, based in Horsham, Pennsylvania. Amedra was acquired by Impax Laboratories in 2015 and is now part of Amneal Pharmaceuticals following the business combination of Impax and Amneal in May 2018.
In an August 14, 2018 statement, Kaléo said that Auvi-Q (epinephrine injection, USP) auto-injectors are available for prescription and are not affected by the manufacturing delays reported by other epinephrine auto-injector manufacturers and that it has sufficient supply to meet any anticipated demand.
The FDA also recently approved the first generic version of EpiPen to Teva Pharmaceutical Industries in August 2018. The FDA approved Teva’s generic versions of Mylan’s EpiPen and EpiPen Jr (epinephrine injection, USP).
The FDA has posted supply information of other approved epinephrine autoinjector products on its website.