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Astellas Receives and FDA Action Letter for Prograf sNDA

TOKYO, March 20, 2007 - Astellas Pharma Inc. today announced that its US subsidiary, Astellas Pharma US, Inc. received an action letter from the U.S. Food and Drug Administration for the Supplemental New Drug Application for the use of immunosuppresant Prograf plus mycophenolate mofetil as an adjunct therapy for the prophylaxis of organ rejection in kidney transplant patients on March 15, 2007. Prograf is currently approved for the prevention of rejection in kidney, liver and heart transplant recipients in the US.

For the full report, see attachment.

Posted: March 2007