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The Food and Drug Administration has granted Astellas Pharma US, Inc. approval for the use of Prograf in conjunction with mycophenolate mofetil for the prevention of organ rejection in kidney transplant recipients. Prograf is a cornerstone therapy for preventing transplant rejection in liver, kidney and heart transplant recipients. The approval came on May 2009 in response to a Supplemental New Drug Application originally submitted in 2006. Prograf's combination use with MMF for heart transplant recipients was approved by the FDA in March 2006.

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