Prevents organ rejection. ANDA 211040, held by Novitium Pharma. Sirolimus.
As of Nov 15, 2026, ANDA 211040 (Sirolimus), held by Novitium Pharma, was first approved by FDA on Jan 28, 2019, with 3 approved supplements and 0 published complete response letters.
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 - 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 |
|---|---|---|---|
| Jan 28, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sirolimus1MG/ML · solution;oral | Sirolimus | Rx |
| May 21, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 21, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 21, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 28, 2019 | Original application | Approved |
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
