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Generic Exclusivity Suit Says US FDA Can’t Deny Prize If It Asks For Extra Data

Executive Summary

Amneal’s Namenda XR lawsuit asserts FDA’s determination that it forfeited 180-day marketing exclusivity on memantine extended-release generics ignores delays resulting from agency’s unexpected request for data from commercial-size lots.

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

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.

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

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.

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