Generic Anti-Seizure Drug Approved
Oxcarbazepine sanctioned for people 4 and older
WEDNESDAY, Oct. 10, 2007 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first generic versions of the anticonvulsant Trileptal (generic name: oxcarbazepine) to treat partial seizures in people 4 years old and older.
Oxcarbazepine tablets in strengths of 150 mg., 300 mg., and 600 mg. will be produced by Roxane Laboratories Inc., Glenmark Pharmaceuticals Ltd., and Sun Pharmaceutical Industries Ltd.
Trileptal, made by Novartis, was the 74th best-selling brand-name medication in the United States, according to the publication Drug Topics, the FDA said in a statement.
Some cases of serious skin reaction have been reported in people who used Trileptal, the agency said. Other side effects may include dizziness and drowsiness.
Visit the FDA to learn more.