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Apotex Corp.

U.S. FDA grants approval for zonisamide capsules for epilepsy

Published in Food and Drug Law Weekly, January 27th, 2006

Apotex Corp. announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for zonisamide capsules in 25 mg, 50 mg and 100 mg strengths.

Shipments of the product will commence immediately.

Apotex' zonisamide is available in 100-count bottles, and is the generic equivalent of Eisai's Zonegran used to treat epilepsy. Annual sales for the brand are approximately $174 million.

The Apotex Group manufactures oral solids, liquids, injectables, nasal sprays, ophthalmics and inhalation solutions.

Zonegran is a registered trademark of...

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