TACROLIMUS | N050709 | ASTELLAS PHARMA US INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 re Suitability Petition from Hyman, Phelps & McNamara PC FDA-2021-P-0083 Hyman, Phelps & McNamara PC filed this suitability petition regarding tacrolimus capsules, requesting FDA guidance on the appropriateness of an immediate-release tacrolimus capsule formulation for regulatory approval. The petition addresses dosing, administration, warnings, and clinical consideratio | Suitability | 2021-01-26 | Granted | Hyman, Phelps & McNamara PC |
Attachment 2 re Suitability Petition from Hyman, Phelps & McNamara PC FDA-2021-P-0083 Hyman, Phelps & McNamara PC filed a suitability petition regarding PROGRAF (tacrolimus), an immunosuppressant drug approved under NDA for prophylaxis of organ rejection in kidney, liver, and heart transplant patients. The petition requests guidance on the appropriateness and regulatory pathway for d | Suitability | 2021-01-26 | Granted | Hyman, Phelps & McNamara PC |
Astellas Pharma US, Inc. - Citizen Petition FDA-2007-P-0111 Astellas Pharma US, Inc., the NDA holder for Prograf (tacrolimus), filed this petition under section 505(b) and (j) of the FDCA requesting that the FDA require bioequivalence studies in transplant patients for orally administered narrow therapeutic index immunosuppressants, mandate specific labeling | 505(q) | 2008-05-23 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| ODE-360 | Jul 16, 2028 | Active |