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NCE Market Exclusivity: Eisai Targets DEA Scheduling Delays, Pozen Pushes Bill For Combo Products

Executive Summary

Eisai citizen petition requests Belviq and Fycompa approval dates coincide with final DEA scheduling; Pozen advocates exclusivity for new combinations of previously approved molecules.

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Will DEA Wind The PDUFA Clock? Scheduled Drugs May Get Complete Response Letters

Eisai sues FDA seeking longer NCE exclusivity for Fycompa and Belviq.

Eisai Asks U.S. Court Of Appeals To Set Deadline For DEA Scheduling Of Its Epilepsy Drug Fycompa

Eisai says the U.S. Drug Enforcement Administration scheduling delay – 10 months after U.S. FDA approval and seven months after the U.S. Department of Health and Human Services submitted a scheduling recommendation – is “unreasonable and egregious.” Court filing follows citizen petition to FDA.

Eisai Asks Court To Set Deadline For DEA Scheduling Of Its Epilepsy Drug Fycompa

Eisai says DEA’s scheduling delay – 10 months after FDA approval and seven months after HHS submitted a scheduling recommendation – is “unreasonable and egregious.” Court filing follows citizen petition to FDA.

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