Eisai launches legal action after "unreasonable" delay for its epilepsy drug
Japanese drug major Eisai (TYO: 4523) has taken legal action in the USA over the delay of the recommendation of its epilepsy drug Fycompa (perampanel).
Yesterday it filed a petition with the US Court of Appeals for the District of Columbia asking the court to direct the Drug Enforcement Administration (DEA) to promptly schedule the company's epilepsy drug so that it can make it available to patients.
The drug was approved by the US Food and Drug Administration in October as an adjunctive therapy for the treatment of partial onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older. The FDA sent its scheduling recommendation to the DEA in January, but it still has not begun the scheduling process.
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