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Roche oral Cytovene reduces incidence of CMV in liver transplants by 79%; company plans SNDA filing.

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Executive Summary

ROCHE PLANS ORAL CYTOVENE SNDA FOR PROPHYLAXIS OF CMV in liver transplant patients, the company said May 29. Roche made known its plans to file a supplemental NDA for oral ganciclovir when it presented data from a study showing a 79% reduction in the overall incidence of CMV in liver transplant patients at the American Society of Transplant Surgeons meeting in Dallas. Cytovene I.V. is the only product approved for prophylaxis of CMV in solid organ transplants.

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