New Delhi, Jun 25 (UNI) Pharma major Ranbaxy Laboratories Ltd today said it has received tentative approval from the US Food and Drug Administration (FDA) to manufacture and market 450 mg tablets of Valganciclovir Hydrochloride, which is used for preventing blindness in the AIDS patients.
Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients.
Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, which provides 180-day marketing exclusivity, the company said in a statement.
Total annual market sales for the tablets were 239 million dollars as on March 2008.
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