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Astellas' Once-Daily Prograf Receives Mixed Decisions For Three Prophylaxis Claims

This article was originally published in PharmAsia News

Executive Summary

Astellas Pharma's once-daily immunosuppressant Prograf MR, a modified-release formulation of tacrolimus, is "approvable" in the U.S. for prophylaxis of organ rejection in kidney and liver transplantation but "not approvable" for heart transplant patients, the company said Jan. 23

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Astellas Tacrolimus Approval Remains At Bay

Astellas Pharma has met with another snag in its attempt to win FDA approval for the once-daily version of its immunosuppressant Prograf (tacrolimus) with receipt of an FDA "approvable" letter for prophylaxis of organ rejection in liver transplant patients

Astellas Tacrolimus Approval Remains At Bay

Astellas Pharma has met with another snag in its attempt to win FDA approval for the once-daily version of its immunosuppressant Prograf (tacrolimus) with receipt of an FDA "approvable" letter for prophylaxis of organ rejection in liver transplant patients

Astellas’ Once-Daily Tacrolimus Again “Approvable” For Kidney Transplant Patients

Astellas Pharma received a second U.S. FDA "approvable" letter for use of its long-lasting immunosuppressant FK506 in kidney transplant patients, the company said March 14.

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