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.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.