FDA approves Fycompa (perampanel) oral suspension for epilepsy as alternative to tablet form- Eisai
The FDA has approved Fycompa (perampanel) CIII Oral Suspension, from Eisai, as adjunctive therapy for 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 of age and older. The oral suspension formulation is a bioequivalent, interchangeable alternative to the Fycompa tablet formulation.
The approval of Fycompa Oral Suspension was based on a bioequivalence (BE) study that demonstrated BE between a single dose of perampanel oral suspension and a single dose of perampanel tablet, when administered under fasted conditions in healthy subjects.
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