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Amneal Loses Bid For 180-Day Generic Exclusivity On Namenda XR

 
• By Sue Sutter

US FDA's demand for commercial-scale data for memantine extended-release during ANDA review did not amount to change in 'requirements for approval,' judge rules, upholding agency determination that Amneal forfeited marketing exclusivity for failure to obtained tentative approval within 30 months.

The US FDA's request for data beyond what it deems necessary to review an abbreviated new drug application (ANDA) does not necessarily constitute a change in approval requirements that would preserve a first-filer's 180-day generic marketing exclusivity, a federal court has ruled.

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More from Biosimilars & Generics

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• By Dave Wallace

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