Astagraf XL Approval History
- FDA approved: Yes (First approved July 19th, 2013)
- Brand name: Astagraf XL
- Generic name: tacrolimus
- Dosage form: Extended-Release Capsules
- Company: Astellas Pharma US, Inc.
- Treatment for: Organ Transplant, Rejection Prophylaxis
Astagraf XL (tacrolimus) is a calcineurin-inhibitor immunosuppressant for the prophylaxis of organ rejection in patients receiving a kidney transplant.
Development History and FDA Approval Process for Astagraf XL
|Jul 22, 2013||Astellas Announces FDA Approval of Astagraf XL (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection|
|Dec 26, 2005||NDA for Immunosuppressant FK506 Modified Release Formulation Submitted in the US|
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