Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation. Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation. Safety and efficacy of CsA withdrawal has not been established in high risk patients ( 1.1, 1.2, 14.3 ). Sirolimus is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2014 | Original application | Approved | None posted |
| Aug 31, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 31, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 31, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Aug 31, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 31, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 31, 2023 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jan 14, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 14, 2016 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 27, 2014 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
