Cipla gets FDA OK for generic Valcyte
Cipla has received the Food and Drug Administration’s green light for valganciclovir tablets in a 450 mg dosage strength.
The product, which is a generic version of Roche's Valcyte, is a deoxynucleoside analogue cytomegalovirus, or CMV DNA polymerase inhibitor, indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome, and prevention of CMV disease in kidney, heart and kidney-pancreas transplant patients at high risk.
The product had a market value of approximately $79 million for the 12-month period ending September 2018, according to IQVIA.
The product, which is a generic version of Roche's Valcyte, is a deoxynucleoside analogue cytomegalovirus, or CMV DNA polymerase inhibitor, indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome, and prevention of CMV disease in kidney, heart and kidney-pancreas transplant patients at high risk.
The product had a market value of approximately $79 million for the 12-month period ending September 2018, according to IQVIA.