FDA Approves First Generic EpiPen (epinephrine)

The FDA has approved the first generic version of Mylan’s EpiPEN and EpiPen Jr (epinephrine) auto injector used to treat emergency allergic reactions, such as the life-threatening anaphylaxis. The generic epinephrine auto-injector has been green flagged to market in 0.3 mg and 0.15 mg strengths for adults and pediatric patients weighing more than 33 pounds. FDA Commissioner Scott Gottlieb, M.D. states “Today’s 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.” Read the full FDA news release here.