Nexium Generics: Ranbaxy’s Exclusivity Loss Is Teva’s Gain
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.
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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.
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.
The generic drug maker’s Ranbaxy USA Inc. subsidiary pleads guilty to seven felony counts brought in connection with a longstanding government investigation into data integrity issues and manufacturing violations at two Indian sites, but while the settlement eliminates some worries for the firm, operations still face the weight of a FDA consent decree.