New Delhi, June 30, 2003
Ranbaxy Laboratories Limited (Ranbaxy), announced today that the Company 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.
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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 Mr. 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.”
Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India, having established operations in the U.S. in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, U.S. operations achieved sales of U.S. $ 296 Mn, a growth of 162% over the corresponding year. During 2002, RPI filed 23 ANDAs and received 11 approvals. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest in the U.S. generics market.
Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, manufactures and markets branded generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 70 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 25 countries and manufacturing operations in 7 countries.
Cytovene® is a registered trademark of Roche Palo Alto, LLC