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Prograf Ads Mislead On CV, Nephrotoxicity Risk – DDMAC

This article was originally published in The Pink Sheet Daily

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Executive Summary

Warning letter to Astellas is not the first time FDA has cited Prograf ads for downplaying risks.

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

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

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

Company also inks monoclonal antibody deal with Kirin Brewery.

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

Company also inks monoclonal antibody deal with Kirin Brewery.

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