Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

This article was originally published in PharmAsia News

Executive Summary

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.

You may also be interested in...



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

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

Eisai Wins FDA Approval For Novel, Once-Daily Seizure Drug Fycompa

Eisai’s Fycompa becomes only the second drug with a new mechanism of action approved by FDA for epilepsy in the last decade.

Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov

Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data.

Topics

Related Companies

UsernamePublicRestriction

Register

SC085248

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel