Status Of Ranbaxy’s First Filer Status For Dioxan Remains A Mystery After Judge Tosses Mylan Lawsuit
This article was originally published in PharmAsia News
Executive Summary
Court says U.S. FDA handled changed USP monograph appropriately, but ruling sheds no new light on the status of first-filer Ranbaxy’s tentatively approved valsartan ANDA or when the first generic version of Novartis’ single-ingredient anti-hypertensive agent will enter the market.