Ranbaxy sues USFDA; US Court to hear motion

The hearing on Ranbaxy's motion suing the USFDA over stripped tentative approvals for generic Valcyte and Nexium is scheduled for tomorrow in the US District Court. USFDA had revoked tentative approvals granted to Ranbaxy for generic versions of two drugs - AstraZeneca's heartburn drug Nexium & Roche's antiviral drug Valcyte.Ranbaxy has first-to-file status, meaning eligibility for six months of generic sales exclusivity for both these drugs. However, the final approvals for these drugs were delayed because of the compliance issues at Ranbaxy's plants.