FUJISAWA PROGRAF PHASE IV STUDY COMMITMENTS
Executive Summary
FUJISAWA PROGRAF PHASE IV STUDY COMMITMENTS include "the performance of additional clinical, pharmacology/toxicology, and pharmacokinetic studies; collection of certain data; and development of a new dosage form," FDA told the company in its April 8 approval letter for the immunosuppressant. Prograf (FK- 506/tacrolimus) is approved for prophylaxis of organ rejection in patients receiving allogeneic liver transplants.