First EpiPen Generics Get FDA Approval
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceuticals’ generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths, the first generic versions of Mylan’s EpiPen and EpiPen Jr. According to FDA Commissioner Scott Gottlieb, 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.”
Though other injectors are available, these are the first FDA has said are the equivalent of the EpiPen, which means they can automatically be substituted for EpiPen in pharmacies across the United States. The price of the drugs and their launch date were not available as of this writing.
References
FDA Approves First EpiPen Generics. U.S. Food and Drug Administration News, Aug. 21, 2018. Accessed at www.fdanews.com/articles/188081-fda-approves-first-epipengenerics?utm_campaign=Drug%20Daily%20Bulletin&utm_source= hs_email&utm_medium=email&utm_content=65327858&_hsenc =p2ANqtz-9y44i6Ivqz32HfSSSRLbegEzA8WpJNsUbyvwF_ 0pzkXVD72yWZFQObTNHodNMvrqq40X0D2xOGWwbg PhIN10Q-bspLoA&_hsmi=65327858.
