Barr receives approval for generic KYTRIL tablets

Jan 3 2008

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s KYTRIL (granisetron hydrochloride) Tablets, 1mg (eq to 1 mg 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 (granisetron hydrochloride) Tablets, 1 mg (eq to 1 mg base) 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 approximately $88 million for the twelve months ended October 2007, based on IMS sales data.