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Banzel News

Eisai Receives Approval for Antiepileptic Drug Banzel (rufinamide) As Adjunctive Treatment For Pediatric Patients

Posted 15 Feb 2015 by Drugs.com

Tokyo, Japan – February 16, 2015 – Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has received approval of an additional pediatric indication for Eisai’s antiepileptic drug (AED) Banzel (rufinamide) from the U.S. Food and Drug Administration (FDA). Through this approval, Banzel, which had been approved for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years older and adults, is now additionally approved for the same indication in pediatric patients from one to less than four years of age in the United States. The additional indication approval is based on an interim analysis of a Phase III clinical trial (Study 303) in pediatric patients from one to less than four years of age comparing Banzel with other existing AEDs as add-on treatments. The study showed that the pharmacokinetic and safety profiles are c ... Read more

Related support groups: Seizures, Banzel, Lennox-Gastaut Syndrome, Rufinamide

Epilepsy Drugs in Pregnancy May Affect Infants' Fine Motor Skills

Posted 25 Sep 2013 by Drugs.com

WEDNESDAY, Sept. 25 – Young children exposed to epilepsy drugs in the womb are at increased risk of having impaired fine motor skills, according to a new study. Exposure to the drugs in breast milk, however, does not appear to pose a threat. Researchers looked at data collected from Norwegian mothers about their children's language, behavior, and motor and social skills at the ages of 6 months, 18 months and 36 months. The women also provided information on breast-feeding during the first year for the study, which was published online Sept. 23 in the journal JAMA Neurology. Of the children in the study, 223 were exposed to one or more epilepsy drugs in the womb. At age 6 months, 11.5 percent of infants whose mothers took epilepsy drugs during pregnancy had impaired fine motor skills (which involve small muscle movements) compared with less than 5 percent of those who were not exposed ... Read more

Related support groups: Klonopin, Seizures, Clonazepam, Ativan, Valium, Lyrica, Lamictal, Topamax, Lorazepam, Depakote, Epilepsy, Diazepam, Keppra, Lamotrigine, Tegretol, Topiramate, Dilantin, Trileptal, Pregabalin, Carbamazepine

FDA Approves Banzel (rufinamide) Oral Suspension, 40 mg/mL

Posted 7 Mar 2011 by Drugs.com

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Mar 4, 2011 - Eisai Inc. today announced that the U.S. 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. "The development of an oral suspension formulation further exemplifies Eisai's human health care (hhc) mission of keeping patients' needs at the forefront of all that we do." About ... Read more

Related support groups: Banzel, Rufinamide

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Lennox-Gastaut Syndrome

Banzel Patient Information at Drugs.com