Ranbaxy’s Valsartan ANDA Wins FDA Approval After Lengthy Delay
This article was originally published in The Pink Sheet Daily
Executive Summary
Regulatory nod gives Ranbaxy green light to launch its generic version of Novartis’ Diovan with 180-day exclusivity; other ANDA holders may continue to challenge Ranbaxy’s hold on 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.
FTC Commissioner Recusal Decisions Should Be Public, US Chamber Of Commerce Says
Chamber files petition to have FTC amend its disqualification rules to have commissioners explain their rejection of recusal requests. FTC is seeking public comments on the petition.
FTC Merger Guidelines Cast ‘Perilous Shadow’ Over Biopharma
BIO objects to guidelines seeking to block mergers that would eliminate a potential entrant in a concentrated market and give greater scrutiny to transactions that are part of a series of company deals. APhA and NCPA call for FTC to consider more factors in PBM mergers.