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.
For more information call (888) 422-4743 or visit Eisai.com.