Endo Approved for Generic Valcyte

Endo announced that Qualitest, its subsidiary, has received final approval from the Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Valganciclovir Tablets, the generic version of Roche’s Valcyte.

Valcyte is a nucleoside analog indicated for the treatment of AIDS-related cytomegalovirus (CMV) retinitis, prevention of CMV disease in kidney, heart, or kidney-pancreas transplant adult patients at high risk, and prevention of CMV disease in kidney and heart transplant pediatric patients (4 months to 16 years old) at high risk.

Valganciclovir is an L-valyl ester (prodrug) of ganciclovir that exists as a mixture of two diastereomers. After oral administration, both diastereomers are rapidly converted to ganciclovir by intestinal and hepatic esterases. Ganciclovir is a synthetic analogue of 2′-deoxyguanosine, which inhibits replication of human CMV in cell culture and in vivo.

Valganciclovir Tablets will be available in a 450mg strength.

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