Ranbaxy Exclusivity Implosion Pushes Valcyte Generics Towards Launch; Nexium Remains ‘Very Hazy’
This article was originally published in The Pink Sheet Daily
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.
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But court finds FDA has authority to correct its mistakes and revoke Ranbaxy’s tentative ANDA approvals
Teva’s readiness for approval prompts FDA conclusion that Ranbaxy forfeited its rights to 180-day exclusivity for AstraZeneca’s proton pump inhibitor; Ranbaxy is still making its case in court, but episode is suggestive of FDA’s increasing emphasis on application quality.
Agency rejects Sandoz’s assertion that the 30-month period for securing ANDA tentative approval under the MMA’s forfeiture provisions begins to run on the date an application is submitted.