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Roche CellCept labeling discussions continue following Feb. 11 approval of heart transplant indication.

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Executive Summary

ROCHE CELLCEPT LABELING NEGOTIATIONS CONTINUE AFTER APPROVAL FOR HEART TRANSPLANT indication. CellCept (mycophenolate mofetil) was approved Feb. 11 for use in combination with cyclosporine and corticosteroids for the prevention of organ rejection following cardiac transplants. Roche said it would begin promoting CellCept for the new indication once labeling negotiations have been completed and after FDA has cleared its promotional materials. The company said CellCept's price would not change; the cost for a 3 g daily dose for the cardiac indication would be $19.14.

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