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Astellas Receives FDA Approval for Use of Prograf(R) (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients
Date:5/28/2009

DEERFIELD, Ill., May 28 /PRNewswire/ -- The Food and Drug Administration (FDA) has granted Astellas Pharma US, Inc. approval for the use of Prograf(R) (tacrolimus) in conjunction with mycophenolate mofetil (MMF) 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 19, 2009 in response to a Supplemental New Drug Application (sNDA) 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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"Prograf + MMF has been an accepted and successful immunosuppressant regimen for the transplant community for more than 10 years," said Flavio Vincenti, M.D., Professor of Clinical Medicine, University of California, San Francisco, Division of Nephrology. "This FDA approval recognizes the most commonly used regimen of transplant centers and reinforces the importance of this combination therapy in the treatment of kidney and heart transplant recipients."

"The FDA approval of Prograf + MMF for use in kidney transplant patients is a milestone for the transplant community as a whole, but most of all it is a milestone for all the patients in the U.S. as it will facilitate the development of new immunosuppressive drugs," said Goran B. Klintmalm, M.D., Ph.D., Chairman and Chief of the Baylor Regional Transplant Institute, Dallas/Fort Worth. "It allows us to use the current standard of care as the control arm in future clinical studies to further advance the timely clinical development of new agents in transplantation."

Prograf was initially approved by the FDA in 1994 and is currently used in the majority of patients
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