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Astellas Finally Wins FDA Approval For Prograf Successor

 
• By Emily Hayes

Female mortality rate among liver transplant patients had been a major obstacle to approval for extended-release tacrolimus, which was first filed in 2005. But the once-daily drug is now approved for kidney transplant patients.

Astellas Pharma Inc. has managed to win approval in one indication for its once-daily Astagraf XL (tacrolimus extended-release) for kidney transplant patients, several years after an initial filing that spanned three organs.

FDA approved the calcineurin inhibitor as a treatment to prevent organ rejection in kidney transplant patients on July 19. Astellas originally filed for FDA approval in 2005 in kidney, heart...

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