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Prograf FDA Approval History

FDA Approved: Yes (First approved April 8, 1994)
Brand name: Prograf
Generic name: tacrolimus
Dosage form: Capsules, Granules for Oral Suspension and Injection
Company: Astellas Pharma US, Inc.
Treatment for: Organ Transplant, Rejection Prophylaxis

Prograf (tacrolimus) is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants.

Development timeline for Prograf

Jul 20, 2021Approval U.S. Food and Drug Administration Expands Indication for Prograf for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients
May 28, 2009Approval Astellas Receives FDA Approval for Use of Prograf (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients

Further information

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