Bionpharma and Hikma have become the first two companies to obtain final abbreviated new drug application (ANDA) approvals for alternatives to Eisai’s Banzel (rufinamide) 40mg/ml oral suspension. Approvals for the treatments for seizures associated in pediatric and adult patients with Lennox-Gastaut Syndrome came just after the end of a six-month pediatric extension to Eisai’s US patent 7,750,028 on 19 April. But it is currently unclear when the generics will enter the market.
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