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
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.
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In a suit against FDA, Mylan argues that Ranbaxy’s delay in getting tentative approval for its valsartan ANDA within 30 months of submission triggered forfeiture of its 180-day marketing exclusivity.
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