Thursday, January 3, 2008

Teva Announces Approval of Generic Kytril Injection and Tablets

JERUSALEM--(BUSINESS WIRE)--Jan 3, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Applications (ANDA) to market its generic version of Roche's antinauseant and antiemetic agent Kytril(R) (Granisetron Hydrochloride) Injection, 1 mg (base)/mL in 1 mL single-dose vials and 1 mg (base) Tablets. Shipment of these products has commenced.

As the first company to file an ANDA with a Paragraph IV patent certification for Granisetron Hydrochloride Injection, 1 mg (base)/mL in 1 mL single-dose vials, Teva has been awarded 180 days marketing exclusivity for this product.

Kytril(R) Injection and Tablets had annual sales of approximately $34 million and $89 million, respectively in the United States for the twelve months ended September 30, 2007, based on IMS sales data.

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.

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