Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its generic version of Janssen's antipsychotic agent Risperdal (risperidone) tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.

According to a company press release, the shipment of these products has already commenced.

As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.

The brand products had annual sales of approximately $2.6 billion in the United States for the twelve months that ended March 31, 2008, based on IMS sales data.

Today's approval follows an April 11, 2008 order by the United States District Court for the District of Columbia granting a request of the company's subsidiary, Teva Pharmaceuticals USA, Inc., that the FDA relist in the Orange Book US Patent No. 5,158,952 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.