BARR RECEIVES TENTATIVE APPROVAL FOR GENERIC KYTRIL

Barr Pharmaceuticals announced that its subsidiary, Barr Laboratories, has received tentative approval from the FDA for its generic version of Roche's Kytril (granisetron hydrochloride) tablets, 1 mg. The company anticipates receiving final approval following the expiration of Roche's patent in December or in mid-2008 if Roche is granted pediatric exclusivity.

A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods, according to Barr.

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 approximately $90 million for the 12 months ending in November 2006, according to IMS sales data.