BioCentury
ARTICLE | Clinical News

Teva wins first FDA approval for generic EpiPen

August 31, 2018 5:57 PM UTC

FDA approved an ANDA from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) for the first generic version of EpiPen epinephrine auto-injector for the emergency treatment of allergic reactions including anaphylaxis. Mylan N.V. (NASDAQ:MYL) markets the original EpiPen and an authorized generic version; at least two additional authorized generics are on the market.

Mylan has attracted criticism in recent years for hiking the price of EpiPen; the product's wholesale acquisition cost (WAC) tripled from 2012 to 2016...