Prevents organ rejection. NDA 21110, held by Pf Prism Cv. Sirolimus.
As of Nov 14, 2026, NDA 21110 (Rapamune), held by Pf Prism Cv, was first approved by FDA on Aug 25, 2000, with 64 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.
| May 28, 2015 | Supplement 73Efficacy (new indication or use) · Priority review | Approved | |
| Jan 14, 2008 | Supplement 43Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2007 | Supplement 37Efficacy (new indication or use) | Approved | |
| Jun 2, 2006 | Supplement 32Efficacy (new indication or use) | Approved | |
| Mar 11, 2005 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Apr 11, 2003 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 25, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Rapamune1MG · tablet;oral | Sirolimus | RxReference drug |
| Rapamune2MG · tablet;oral | Sirolimus | RxReference drug |
| Rapamune5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Sirolimus | DiscontinuedReference drug |
| Rapamune0.5MG · tablet;oral | Sirolimus | RxReference drug |
| Aug 22, 2022 | Supplement 87Labeling · Standard review | Approved | |
| Aug 22, 2022 | Supplement 88Labeling · Standard review | Approved | |
| Aug 9, 2021 | Supplement 86Labeling · Standard review | Approved | |
| Jan 2, 2020 | Supplement 85Labeling · Standard review | Approved | |
| Jul 15, 2019 | Supplement 83Labeling · Standard review | Approved | |
| Apr 5, 2019 | Supplement 84Labeling · Standard review | Approved | |
| May 23, 2018 | Supplement 80Labeling · Standard review | Approved | |
| Jan 12, 2018 | Supplement 81Labeling · Standard review | Approved | |
| Apr 11, 2017 | Supplement 76Labeling · Standard review | Approved | |
| Nov 5, 2015 | Supplement 75Labeling · Standard review | Approved | |
| May 28, 2015 | Supplement 73Efficacy (new indication or use) · Priority review | Approved | |
| Mar 30, 2015 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Mar 6, 2015 | Supplement 74Labeling · Standard review | Approved | |
| Jul 3, 2014 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Jan 29, 2014 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Nov 6, 2013 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| May 30, 2013 | Supplement 68Labeling · Standard review | Approved | |
| Mar 7, 2013 | Supplement 67Labeling · Standard review | Approved | |
| Dec 10, 2012 | Supplement 65Labeling · Standard review | Approved | |
| Jul 11, 2011 | Supplement 59Labeling | Approved | |
| Jun 6, 2011 | Supplement 60REMS | Approved | |
| Nov 23, 2010 | Supplement 55Labeling | Approved | |
| Nov 23, 2010 | Supplement 57Labeling | Approved | |
| Nov 8, 2010 | Supplement 58Labeling | Approved | |
| Jul 2, 2010 | Supplement 56Labeling | Approved | |
| Apr 22, 2010 | Supplement 53Labeling | Approved | |
| Apr 22, 2010 | Supplement 54Labeling | Approved | |
| Jan 25, 2010 | Supplement 52Manufacturing · Standard review | Approved | |
| Oct 8, 2009 | Supplement 51Labeling | Approved | |
| Sep 24, 2009 | Supplement 50Labeling · Standard review | Approved | |
| Jan 29, 2009 | Supplement 49Labeling · Standard review | Approved | |
| Mar 5, 2008 | Supplement 48Labeling · Standard review | Approved | |
| Mar 5, 2008 | Supplement 47Labeling · Standard review | Approved | |
| Jan 14, 2008 | Supplement 43Efficacy (new indication or use) · Standard review | Approved | |
| Oct 17, 2007 | Supplement 45Labeling · Standard review | Approved | |
| May 2, 2007 | Supplement 39Labeling · Standard review | Approved | |
| Jan 30, 2007 | Supplement 37Efficacy (new indication or use) | Approved | |
| Jan 12, 2007 | Supplement 38Labeling · Standard review | Approved | |
| Jan 9, 2007 | Supplement 35Labeling · Standard review | Approved | |
| Oct 19, 2006 | Supplement 36Labeling · Standard review | Approved | |
| Jun 2, 2006 | Supplement 32Efficacy (new indication or use) | Approved | |
| Jun 2, 2006 | Supplement 34Labeling · Standard review | Approved | |
| Mar 10, 2006 | Supplement 33Manufacturing | Approved | None posted |
| Oct 7, 2005 | Supplement 30Labeling · Standard review | Approved | |
| Oct 7, 2005 | Supplement 31Labeling · Standard review | Approved | |
| Jun 30, 2005 | Supplement 27Labeling · Standard review | Approved | |
| Jun 30, 2005 | Supplement 28Labeling · Standard review | Approved | |
| Mar 11, 2005 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Jul 20, 2004 | Supplement 20Labeling · Standard review | Approved | |
| Feb 23, 2004 | Supplement 18Manufacturing · Standard review | Approved | |
| Oct 2, 2003 | Supplement 15Labeling · Standard review | Approved | |
| Apr 11, 2003 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2003 | Supplement 13Labeling · Standard review | Approved | |
| Mar 19, 2003 | Supplement 14Labeling · Standard review | Approved | |
| Jan 31, 2003 | Supplement 11Labeling · Standard review | Approved | |
| Jan 23, 2003 | Supplement 1Labeling · Standard review | Approved | |
| Jan 23, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Jan 23, 2003 | Supplement 7Labeling · Standard review | Approved | |
| Jan 23, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Jan 23, 2003 | Supplement 10Labeling · Standard review | Approved | |
| Aug 22, 2002 | Supplement 3Manufacturing · Standard review | Approved | |
| Jun 5, 2002 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 7, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 6, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 25, 2000 | Original applicationNew dosage form · Standard review | 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
