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Roche Valcyte

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Valganciclovir is approved March 29 for induction and maintenance treatment of CMV retinitis in AIDS patients. Valcyte, a prodrug of ganciclovir (Roche Cytovene), will be launched in the spring. Roche says it expects that the oral agent will "replace and build upon Cytovene in the marketplace." Cytovene is approved for maintenance use in CMV. The firm plans to file a Valcyte sNDA in mid-2002 for CMV prophylaxis in solid organ transplant recipients and may evaluate whether to continue marketing oral Cytovene if the transplant indication is approve
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