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.
You may also be interested in...
Mylan vs. FDA (And Ranbaxy): Diovan Exclusivity Forfeiture Edition
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.
Drug Promotion: Growth In Digital Marketing Warrants New Oversight Approaches, Experts Say
Panelists at a recent Duke-Margolis meeting cite growing use of native ads and patient influencers, as well as the limited attention given to presentation of risk information, in calling for a re-examination of how pharmaceutical promotion on digital platforms is regulated.
Lantidra Chronology: 19 Years From IND Submission To Approval For The Cellular Therapy
Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of CellTrans’ treatment for type 1 diabetes.