FDA Approves Generic Version of Anticonvulsant Trileptal

Oxcarbazepine is approved in the treatment of partial seizures in adults and in children aged 4 years and older

WEDNESDAY, Oct. 10 (HealthDay News) -- The U.S. Food and Drug Administration has approved generic versions of the anticonvulsant drug Trileptal (oxcarbazepine) for the treatment of partial seizures in adults and children aged 4 years and older, either as monotherapy or in combination with other medications.

Oxcarbazepine tablets are available in 150 mg, 300 mg, and 600 mg strengths. Roxane Laboratories, Inc., Glenmark Pharmaceuticals Limited and Sun Pharmaceutical Industries Limited all manufacture the drug. Trileptal was rated the 74th best-selling brand-name drug in 2006, according to Drug Topics.

Commonly reported side effects with Trileptal use include dizziness and drowsiness. Serious skin reactions have been reported in association with Trileptal use, and patients taking Trileptal who experience a skin reaction should consult with their health care provider.

"FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs," commented Gary J. Buehler, director of FDA's Office of Generic Drugs, in a statement. "The agency ensures that generic drugs are safe and effective, offering alternatives to Americans in choosing their prescription drugs."

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