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The U.S. Food and Drug Administr ...

Posted Nov 10 2008 4:23pm

The U.S. Food and Drug Administration has approved the first generic versions of Trileptal (oxcarbazepine), an anticonvulsant drug. Generic oxcarbazepine is FDA-approved for use alone or in combination with other medications in the treatment of partial seizures in adults and children aged four years and above. "FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs," said Gary J. Buehler, director of FDA's Office of Generic Drugs. "The agency ensures that generic drugs are safe and effective, offering alternatives to Americans in choosing their prescription drugs." Oxcarbazepine tablets in three strengths (150 milligrams, 300 milligrams and 600 milligrams) are manufactured by Roxane Laboratories Inc., Glenmark Pharmaceuticals Limited, and Sun Pharmaceutical Industries Limited.

Generic Trileptal (oxcarbazepine) approved in U.S.

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