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

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.

A lawsuit over generic versions of Allergan PLC’s Alzheimer’s drug Namenda XR (memantine extended-release) is challenging how FDA determines whether an abbreviated new drug application (ANDA) sponsor has forfeited generic marketing exclusivity.

In a Jan. 27 complaint, Amneal Pharmaceuticals LLC asks the US District Court for the District of Columbia to set aside FDA’s determination that it forfeited 180-day...

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