Barr Receives Approval For Generic KYTRIL Tablets
Barr Laboratories has received final approval from FDA for its generic version of Roche Laboratories'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.