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U.S. Department of Health and Human Services

Safety

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Valcyte (valganciclovir HCl tablets) Oct 2003

Audience: Transplantation and other healthcare professionals

FDA and Roche notified healthcare professionals of the findings of an active comparator study of Valcyte and ganciclovir in heart, liver, kidney, and kidney-pancreas transplant patients at high risk for CMV disease. Based on those findings: (1) Valcyte is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk, (2) Valcyte is not indicated for use in liver transplant patients, and (3) The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients, such as lung transplant patients, have not been established.

[September 30, 2003 - Letter - Roche]
[September 2003 - Revised label - Roche]