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FDA approves Eisai’s BANZEL® as an adjunctive treatment of seizures in kids (Age 1-4) with LGS
"The approval of BANZEL for pediatric patients, one to four years of age, represents an important milestone, as it may help to address an unmet need of younger patients with Lennox-Gastaut Syndrome," said Lynn Kramer, Chief Clinical Officer (ECL) and President, Neuroscience & General Medicine, PCU Eisai Product Creation Systems, Eisai Inc. "At Eisai, we are committed to our corporate human health care (hhc) mission and are proud to help serve patients and families living with this rare condition."
FDA approval was based on pharmacokinetic bridging study of a Phase III clinical trial (study 303) in patients 1 to 4 years of age. According to the study the pharmacokinetic and safety profiles are consistent with those seen in ages 4 and above.
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Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives(