FDA Approves First EpiPen Generics

The FDA approved the first generic versions of Mylan’s EpiPen and EpiPen Jr., giving Teva permission to market its generic epinephrine auto-injector in 0.3mg and 0.15mg strengths.

The company didn’t say how much it would charge for the generic product.

FDA Commissioner Scott Gottlieb said the approval is part of FDA’s “longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.”