The US Food and Drug Administration (FDA) granted final approval for Teva Pharmaceutical Industries' Abbreviated New Drug Applications (ANDA) to market its generic version of Roche's antinauseant and antiemetic agent Kytril (Granisetron Hydrochloride) injection, 1 mg (base)/mL in 1 mL single-dose vials and 1 mg (base) tablets. The company has also commenced the shipment of these products.
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 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.