Financial Daily from THE HINDU group of publications
Tuesday, Jul 01, 2003
Financial Daily from THE HINDU group of publications Tuesday, Jul 01, 2003 |
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Corporate
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Announcements Ranbaxy gets USFDA nod AIDS drug Our Bureau
NEW DELHI, June 30 RANBAXY Laboratories Ltd (RLL) on Monday announced that it had received approval from the US regulatory authority for its generic version of Cytovene, an anti-viral drug from the Roche stable. Meanwhile, the company has also got six months' exclusivity on the marketing of the drug in the US market. The US Food and Drug Administration's (USFDA) approval allowed the manufacture and commercialisation of Ranbaxy's Ganciclovir Capsules, in 250-mg and 500-mg strengths — since it was bioequivalent and hence therapeutically equivalent to the listed drug Cytovene{lcub}logicalnot_shy{rcub} Capsules, 250-mg and 500-mg respectively of Roche Palo Alto, LLC, a company communication said.252{gt}The drug would be marketed in the US by RLL's wholly owned subsidiary Ranbaxy Pharmaceuticals Inc (RPI) and according to RPI's President, Mr Dipak Chattaraj, {lcub}ldquo{rcub}The opportunity to market Ganciclovir prior to patent expiry, is a result of co-ordinated efforts amongst our scientists, business and legal teams. Ranbaxy is now in an exclusive position to market this product for six months in the US Healthcare System providing an affordable, generic form of Ganciclovir.{lcub}rdquo{rcub} 252{gt}According to industry sources, sales for Ganciclovir Capsules totalled $31.9 million in 2002 and the drug is indicated for the prevention of Cytomegalovirus (CMV) disease in solid organ transplant recipients. It is also used in individuals with advanced HIV infection at a risk for developing CMV, an opportunistic disease associated with AIDS. 252{gt}Cytovene{lcub}logicalnot_shy{rcub} 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./body{gt}
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