Ranbaxy Exclusivity Implosion Pushes Valcyte Generics Towards Launch; Nexium Remains ‘Very Hazy’
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA rescinds Ranbaxy’s esomeprazole and valganciclovir ANDA tentative approvals because of GMP compliance issues; firm loses its 180-day marketing exclusivity for valganciclovir but not for esomeprazole.