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Published on 11 October 2007

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Generic versions of oxcarbazepine gain US approval

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The FDA has approved the first generic versions of the anticonvulsant Trileptal® (oxcarbazepine), currently manufactured by Novartis.

The FDA gave the green light to generic oxcarbazepine for use alone or in combination with other medications in treating partial seizures in adults and children aged four and over.

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

Gary Buehler, director of the FDA’s Office of Generic Drugs, said: “FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.”

The labelling of the generic products may differ from that of Trileptal because parts of the Trileptal labelling are protected by patents.

According to the publication Drug Topics, in 2006 Trileptal was the 74th best-selling proprietary drug by retail dollars in the USA.

However, serious skin reactions have been reported in children and adults who have used Trileptal, and common side-effects include dizziness and drowsiness.

Copyright © PA Business 2007

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