Fycompa sNDA Under Review for Primary Generalized Tonic-Clonic Seizures
Eisai announced that the Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Fycompa (perampanel) CIII for the treatment of primary generalized tonic-clonic (PGTC) seizures in patients 12 years and older. Fycompa is an oral non-competitive AMPA glutamate receptor antagonist.
On August 19, 2014, Eisai had submitted the sNDA for Fycompa to the FDA.
Fycompa is already indicated as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy ages 12 years and older.
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