UCB Receives EMEA Positive Opinion and FDA Approvable Letter for Keppra® (levetiracetam) Intravenous Administration
UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion to approve marketing authorisation of Keppra® (levetiracetam) Concentrate (100 mg/mL) as an intravenous administration and for use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children of four years of age and older with epilepsy.
UCB also received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for Keppra® (levetiracetam) Injection 100 mg/mL for use as adjunctive therapy in the treatment of partial onset seizures in adult patients with epilepsy. In the approvable letter, the FDA has requested revised product labelling as well as some additional information regarding manufacturing to finalize its review. UCB has already submitted the requested information to the FDA.
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