Teva Announces Approval Of Generic Trileptal(R) Tablets

Main Category: Epilepsy
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Dec 2007 - 1:00 PDT

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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' antiepileptic therapy Trileptal(R) (Oxcarbazepine) Tablets, 150 mg, 300 mg and 600 mg. Shipment of the product will begin in the near future.

The brand product had annual sales of approximately $690 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.

Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Europe.

Teva Pharmaceutical Industries Ltd