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UCB plans supplemental NDA on new Keppra data

UCB says it plans to file a supplemental new drug application for Keppra after seeing positive data on its efficacy for partial onset epileptic seizures in children aged from one month to less than four years. The data showed that 43.1 percent of the children experienced a minimum 50 percent reduction in seizure frequency for the treatment period of five days. Patients taking a placebo demonstrated a 19.6 percent reduction in seizures.

- see this release
- check out the AFX report

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FDA approves Keppra. Report
FDA extends Keppra approval. Report
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