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news.Teva Pharmaceutical Industries has announced that the FDA has granted final approval for the company's abbreviated new drug application to market its generic version of Janssen's antipsychotic agent Risperdal tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg and 4mg. Shipment of these products has commenced.
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As the first company to file an abbreviated new drug application (ANDA) containing a Paragraph IV certification for this product, Teva said that it has been awarded a 180-day period of marketing exclusivity.
The approval follows an April 11, 2008 order by the US District Court for the District of Columbia granting a request of the company’s subsidiary, Teva Pharmaceuticals USA, that the FDA relist in the Orange Book the US patent of the company and grant Teva 180-day exclusivity for its Risperidone tablets. The FDA has appealed this decision and a hearing has been scheduled for September 12, 2008.