The FDA approved the first generic versions of Mylan’s EpiPen and EpiPen Jr epinephrine autoinjectors, in a move the agency said would help increase access to the emergency treatment for allergic reactions—and is part of a broader federal mandate to help lower costs for medications that are no longer protected by patents or exclusivities.
Teva Pharmaceuticals was granted approval for its generic epinephrine autoinjectors in 0.3-mg and 0.15-mg strengths, for use in adults and children that weigh more than 33 pounds.
“This approval means patients living with severe allergies who require constant access to lifesaving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” FDA Commissioner Scott Gottlieb, M.D., said in a statement.
Currently, EpiPens can be in short supply, with spot shortages continuing after FDA investigators found problems last year at a Meridian Medical Technologies plant, a Pfizer subsidiary that manufactures the autoinjectors for Mylan. In May, the agency added the EpiPen and injectors from Impax Laboratories to its drug shortages list, after Mylan recalled 80,000 possibly faulty injectors shipped outside the U.S.
The agency said it is also working on new guidance for generic sponsors of complex products, such as drug-device combinations, and has been prioritizing the review of such applications.
“The path to developing generic drug-device combination products like this one is challenging,” Gottlieb said. “We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines.”
The FDA has previously approved competitors to Mylan’s EpiPen under new drug applications, such as Amedra Pharmaceuticals’ Adrenaclick and Kaleo’s Auvi-Q. In addition, Mylan offers its own “authorized generic” version at a lower price without the brand name.