October 10, 2007

FDA OKs first generic version of Trileptal

The U.S. Food and Drug Administration announced approval of the first generic versions of the anti-convulsion drug Trileptal (oxcarbazepine).

The FDA said it approved generic oxcarbazepine for use alone or in combination with other medications in the treatment of partial seizures in adults and children aged 4 years and older.

Oxcarbazepine tablets in three strengths (150 milligrams, 300 milligrams and 600 milligrams) are manufactured by Roxane Laboratories Inc., Glenmark Pharmaceuticals Ltd. and Sun Pharmaceutical Industries Ltd.

According to the publication Drug Topics, Trileptal was the 74th best selling brand-name drug by retail dollars in the United States last year.

FDA OKs first generic version of Trileptal

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