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As of Nov 15, 2026, ANDA 208691 (Sirolimus), held by Glenmark Pharms Ltd, was first approved by FDA on Oct 16, 2020, with 1 approved supplement and 0 published complete response letters.
First approved: Oct 16, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Sirolimus tablets are 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 ). 1.1 Prophylaxis of Organ Rejection in Renal Transplantation Sirolimus tablets are
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