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Teva Pharmaceutical Industries announced today 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 Janssen's antipsychotic agent Risperdal(R) (Risperidone) Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Shipment of these products has commenced
Jerusalem, Israel | June 30, 2008 | Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today 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 Janssen's antipsychotic agent Risperdal(R) (Risperidone) Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Shipment of these products has 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 U.S. 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.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.
SOURCE: Teva Pharmaceutical Industries Ltd. |
