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FDA Sends Approvable Letter for Trileptal (Oxcarbazepine) as Epilepsy Monotherapy

BASEL, SWITZERLAND -- December 13, 2001 -- Novartis announced today that it has received an approvable letter from the US Food and Drug Administration (FDA) for Trileptal® (oxcarbazepine) tablets and oral suspension for use as monotherapy in the treatment of partial seizures in children as young as four years of age.

Trileptal belongs to the class of medications known as antiepileptic drugs (AEDs) and is currently approved for use as both monotherapy and adjunctive therapy in the treatment of partial seizures in adults with epilepsy, and as adjunctive therapy in the treatment of partial seizures in children ages four to 16 with epilepsy.

An approvable letter usually represents the final step before a product receives clearance for marketing in the United States.

"Novartis is very pleased that the FDA has issued an approvable letter for the use of Trileptal as monotherapy in children. We look forward to working closely with the Agency to finalize this process as quickly as possible," said Larry Perlow, Senior Vice President and General Manager, Commercial Operations, Novartis Pharmaceuticals Corporation. "We believe the availability of Trileptal can provide an important new option in the treatment of children with partial seizures."

Many children with epilepsy take multiple medications to control their seizures; however, treating seizure disorders with one medication is preferred as it usually means fewer side effects and improved compliance. Currently, only five other AEDs are approved for use as monotherapy in this age group. However, the use of these drugs in children can be complicated by serious side effects, the need for frequent blood tests, or complex dosing and titration schedules.

Trileptal is approved in more than 50 countries and received clearance for marketing in the US in January 2000. Novartis submitted the supplemental New Drug Application (sNDA) for the pediatric monotherapy indication on 9 February 2001.

SOURCE: Novartis AG

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