Pediatrics

US FDA Grants Pediatric Exclusivity for UCB's Keppra(R)

Published in Medical Letter on the CDC and FDA, June 22nd, 2008

UCB announced that the US Food and Drug Administration (FDA) has granted pediatric exclusivity for Keppra(R) (levetiracetam). The decision was based on pediatric data submitted to the FDA following a written request in 2001. The Keppra(R) US '639 patent was set to expire in July 2008, however, this grant extends the period of exclusivity on Keppra(R) across all licensed indications by six months to January 2009.

UCB also announced that the US FDA has accepted for filing and six-month priority review the supplementary New Drug Application (sNDA) for Keppra(R) as adjunctive treatment of partial onset seizures in infants and children with epilepsy, aged from one month to...

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Source: Medical Letter on the CDC and FDA (2008-06-22)

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