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FDA Approves Rufinamide Oral Suspension for Lennox-Gastaut Syndrome03/04/2011
The Food and Drug Administration (FDA) has approved BANZEL® (rufinamide) Oral Suspension, 40 mg/mL, for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in children 4 years and older and adults. The oral suspension formulation is bioequivalent to the currently marketed BANZEL tablet formulation on a milligram per milligram basis and will be available for prescription use by late March 2011.
“This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form,” said Lonnel Coats, president and CEO of Eisai Inc.
About Lennox-Gastaut Syndrome
Lennox-Gastaut syndrome (LGS) is a rare form of epilepsy that affects 1-4 percent of children with epilepsy. The age of onset is between 1 and 8 years, with peak at 3 to 5 years. LGS affects an estimated 1 in 50,000 to 1 in 100,000 children.
LGS is characterized by a clinical triad of a slow spike-and-wave pattern on an EEG, impairment of cognitive function and multiple types of seizures, including tonic (muscle stiffening), atypical absence (staring) and atonic (loss of muscle tone) seizures being the most common.
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