Teva Announces Approval Of Generic KytrilR Injection And Tablets

 

The U.S. Food and Drug Administration (FDA) has granted final approval for the Teva Pharmaceutical Industries’s 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. 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® 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.