Roche CellCept shipments will begin June 30 following approval as add-on immunosuppressant.
Executive Summary
ROCHE CELLCEPT APPROVAL TOOK LESS THAN SIX MONTHS; shipments will begin June 30 following FDA approval of the immunosuppressant May 3 for use in combination with cyclosporine (Sandoz' Sandimmune) and corticosteroids to prevent kidney transplant rejection. Roche subsidiary Syntex Labs filed NDA 50-722 on Nov. 10 for CellCept (mycophenolate mofetil) 250 mg capsules. Advertising will be handled by the New York City firm Girgenti, Hughes, Butler & McDowell.