SILVER SPRING, Md. – Teva Pharmaceuticals received approval from the U.S. Food and Drug Administration to market its generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions. The company gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. “The approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said Dr. Scott Gottlieb, FDA Commissioner, in a statement. “We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications.” According to the FDA, an authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer, but the labeling or packaging is changed to remove the brand name or other trade dress.
You are here: / / Teva Pharmaceuticals approved to market generic EpiPen