Generic Valcyte Launched by Endo

Endo announced the launch of Valganciclovir Tablets, the first generic version of Roche’s Valcyte to be available in the U.S.

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.

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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 are available in a 450mg strength.

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