At least six PDUFA dates on FDA’s January calendar

Janauary’s FDA decision docket includes PDUFA dates for four new products and two indication extensions. Among the new products is sublingual epinephrine prodrug Anaphylm dibutepinephrine from Acquestive Therapeutics Inc. (NASDAQ:AQST). If approved, it would be the first orally-delivered alternative to injected epinephrine products such as EpiPen for severe allergic reactions. 

Other potential new products include Ebvallo tabelecleucel, from Atara Biotherapeutics Inc. (Nasdaq: ATRA), to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease. The cell therapy is already approved in Europe, but FDA took issue with the third-party manufacturing facility in a complete response letter last year...