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Epilepsy

FDA approves new indication for Topamax as initial monotherapy

Published in Medical Letter on the CDC and FDA, August 7th, 2005

The U.S. Food and Drug Administration (FDA) approved a new use for TOPAMAX (topiramate) Tablets and TOPAMAX (topiramate capsules) Sprinkle Capsules as initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures.

Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.

"Antiepilepsy medications, or neuromodulators, are selected...

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