Barr's generic Kytril gains final FDA approval

Barr Laboratories has received final approval from the US Food and Drug Administration for its generic version of Roche Laboratories' Kytril (granisetron HCl) tablets, 1mg (equal to 1mg base). The company received final approval following the expiration of Roche's patent on December 28, 2007, and plans to launch its product shortly.

Kytril is indicated for the prevention of: nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin; and nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. The product had annual sales of about $88.0 million for the 12 months ended October 2007, based on IMS sales data, said Barr.