Ranbaxy Laboratories got tentative approval from US FDA to manufacture and market Valganciclovir Hydrochloride tablets of 450 mg strengths.
Valganciclovir HCI tablets are used by AIDS patients for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome. Total annual market sales for Valganciclovir HCl Tablets were $239 million.
Valganciclovir HCl is indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [(D+/R-)]).
Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future. Valganciclovir HCl Tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).