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I.V. Keppra "approvable," quick response

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

UCB has responded to a recent "approvable" letter for an intravenous formulation of its antiepileptic Keppra (levetiracetam), the firm reports Feb. 3. FDA had requested "revised product labeling as well as some additional information regarding manufacturing to finalize its review," UCB says. The company hopes I.V. Keppra will be of use in "emergency seizure situations where oral medication is not an option." Keppra would be the first of the newer antiepileptics to be available intravenously, according to UCB. Also on Feb. 3, the formulation received a positive opinion from the European Medicines Agency...

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