Cipla gets USFDA nod for antiviral eye infection drug for AIDS patients
Drug major Cipla Monday said it has received final approval from the US health regulator for Valganciclovir tablets, used in the treatment of viral eye infection in AIDS patients.
Valganciclovir tablets are used in the treatment cytomegalovirus infection (serious viral eye infection of the retina) in AIDS patients and in prevention of cytomegalovirus (CMV) disease after organ transplant.
The approved products is a generic therapeutic equivalent version of Roche's Valcyte.
Cipla has received approval for the product in the strength of 450 mg from the United States Food and Drug Administration (USFDA), the company said in a BSE filing.
Quoting IQVIA (IMS Health) data, Cipla said Valcyte and its generic equivalents had US sales of around USD 79 million for the 12-month period ending September 2018.