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Indian Pharmaceutical major Cipla has announced that it has received final approval pending for the tablets called Valganciclovir, which is used in the treatment of viral eye infection in AIDS patients from the US health regulator USFDA.
The company said in a BSE filing that the approved products is a generic therapeutic equivalent version of Roche’s Valcyte. The strength of the product for which Cipla has received approval from the United States Food and Drug Administration (USFDA) stands at 450 mg.
According to Cipla, Valganciclovir tablets are used in the treatment cytomegalovirus infection, which is a serious viral eye infection of the retina in the AIDS patients and in prevention of cytomegalovirus (CMV) disease after organ transplant.
Cipla while quoting IQVIA (IMS Health) data, stated that Valcyte and its generic equivalents had US sales of around USD 79 million for the 12-month period ending September 2018.
