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Astellas Pharma Inc Announces FDA Approval Of ASTAGRAF XL (tacrolimus extended-release capsules) For Prophylaxis Of Organ Rejection In Adult Kidney Transplant Recipients


Friday, 19 Jul 2013 08:14pm EDT 

Astellas Pharma Inc announced that Astellas Pharma US, Inc. (Astellas), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced that the U.S. Food and Drug Administration (FDA) has approved ASTAGRAF XLTM (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. The two primary, randomized, comparative phase 3 clinical studies to support FDA approval enrolled 1,093 patients (545 on tacrolimus extended-release) in the U.S., Europe, Canada, South America, Australia and South Africa. 

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