Ranbaxy Laboratories Limited has received approval from the US Food and Drug Administration to manufacture and commercialize Ganciclovir Capsules in 250 mg and 500 mg strengths. The Division of Bioequivalence has determined Ranbaxy ' s Ganciclovir Capsules, 250 mg and 500 mg, to be bioequivalent and therefore, therapeutically equivalent to the listed drug Cytovene Capsules, 250 mg and 500 mg, respectively, of Roche Palo Alto, LLC. In 2002, sales for Ganciclovir Capsules totaled $31.9 million (IMS - MAT, April 2003).

Ganciclovir Capsules are indicated for the prevention of Cytomegalovirus (CMV) disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. Cytovene Capsules are also indicated as an alternative to the intravenous formulation for maintenance treatment of CMV retinitis in immuno-compromised patients, including patients with AIDS, in whom retinitis is stable following appropriate induction therapy and for whom the risk of more rapid progression is balanced by the benefit associated with avoiding daily IV infusions.

The product will be made available for sales, marketing and distribution in the US through Ranbaxy ' s wholly owned subsidiary, Ranbaxy Pharmaceuticals Inc. (RPI) as soon as inventories are achieved to support market requirements. The product will be offered through all classes of trade including wholesalers, chain pharmacies and generic distributors that support the dispensing and therapeutic usage of this product.

According to Dipak Chattaraj, President of RPI "The approval of Ganciclovir Capsules represents yet another addition to the expanding RPI product portfolio. The opportunity to market Ganciclovir prior to patent expiry, is a result of coordinated efforts amongst our scientists, business and legal teams. Ranbaxy is now in an exclusive position to market this product for six months in the U.S. Healthcare System providing an affordable, generic form of Ganciclovir."