FDA Approves Teva’s Generic EpiPen
After two years of trying, Israeli generics producer Teva Pharmaceutical Industries has finally gained approval by the US Food and Drug Administration (FDA) for its copy of Mylan’s EpiPen.
The FDA has approved Teva’s generic versions of EpiPen and EpiPen Jr epinephrine auto-injector in 0.3 mg and 0.15 mg strengths for the emergency treatment of allergic reactions, including life-threatening anaphylaxis in adults and children who weigh more than 33 pounds.
“This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” said FDA Commissioner Scott Gottlieb.
Responding to the approval, Teva said it is “applying its full resources to this important launch in the coming months and is eager to begin supplying the market.”
Teva applied and failed in 2016 to get its copy cleared by the FDA, which rejected it because of "certain major deficiencies”. Wells Fargo analyst David Maris said the approval may surprise investors who were thinking it would not happen before 2019.
Mylan once held the market monopoly with its EpiPen, but several other epinephrine auto-injectors are now available. Last December, Mylan itself launched an authorized generic – and much cheaper – version of its EpiPen.