Barr Pharmaceuticals Inc. has announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s Kytril (granisetron hydrochloride) tablets, 1mg (base).
The company anticipates receiving final approval following the expiration of Roche's patent on December 29, 2007, or on June 29, 2008 if Roche seeks and is granted paediatric exclusivity.
Kytril (granisetron hydrochloride) tablets, 1mg (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 $90 million for the twelve months ended November 2006, based on IMS sales data.
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. A tentative approval does not allow the applicant to market the generic drug product.