FDA approves Eisai Banzel oral suspension, 40mg/ml - Pharmaceutical Business review

04 Mar 2011

FDA approves Eisai Banzel oral suspension, 40mg/ml

The US Food and Drug Administration (FDA) has approved Eisai's Banzel (rufinamide) Oral Suspension, 40mg/ml.

Banzel has been approved for the adjunctive treatment of seizures linked with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults.

Eisai claims that its Banzel oral suspension is bioequivalent to currently marketed Banzel tablet formulation on a milligram per milligram basis.

The company said that it will launch the product in late March as a prescription drug.

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