Cipla gets final approval for generic version of Roche’s Valcyte

Mumbai, Nov 12 (IEBusiness) Pharma Major, Cipla Limited today said that it has received final approval for its Abbreviated New Drug Application (ANDA) for Valganciclovir Tablets 450mg from the United States Food and Drug Administration (US FDA).

Cipla’s Valganciclovir Tablets 450mg is AB-rated generic therapeutic equivalent version of Roche’s Valcyte, company said in a filing with BSE.

It is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for use in the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and prevention of CMV disease in kidney, heart, and kidney pancreas transplant patients at high risk.

According to IQVIA (IMS Health), Valcyte and its generic equivalents had US sales of approximately USD79M for the 12-month period ending September 2018. The product is available for shipping immediately.

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