FDA Accepts Fycompa Oral Solution NDA
Eisai announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Fycompa (perampanel) Oral Suspension 0.5mg/mL for adjunctive therapy in the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy ≥12 years old.
Fycompa is an oral medication and the first and only FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. It is currently supplied as 2mg, 4mg, 6mg, 8mg, 10mg and 12mg film-coated tablets.
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