Rapamune

Prevents organ rejection. NDA 21083, held by Pf Prism Cv. Sirolimus.

As of Nov 14, 2026, NDA 21083 (Rapamune), held by Pf Prism Cv, was first approved by FDA on Sep 15, 1999, with 57 approved supplements and 0 published complete response letters.

First approved: Sep 15, 1999
Review: Priority
Supplements approved: 57
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 58 submissions below


May 28, 2015	Supplement 55Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 14, 2008	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 30, 2007	Supplement 29Efficacy (new indication or use)	Approved	Letter
Jun 2, 2006	Supplement 24Efficacy (new indication or use)	Approved	Letter Label
Mar 11, 2005	Supplement 19Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Apr 11, 2003	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 15, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Rapamune1MG/ML · solution;oral	Sirolimus	RxReference drug

All 58 submissions, including labeling and manufacturing supplements


Aug 22, 2022	Supplement 70Labeling · Standard review	Approved	Letter Label Medication Guide
Aug 22, 2022	Supplement 69Labeling · Standard review	Approved	Letter Label
Jan 2, 2020	Supplement 67Labeling · Standard review	Approved	Label Letter
Jul 15, 2019	Supplement 64Labeling · Standard review	Approved	Letter Label
Jun 18, 2019	Supplement 66Labeling · Standard review	Approved	Label Letter
Apr 5, 2019	Supplement 65Labeling · Standard review	Approved	Label Letter
May 23, 2018	Supplement 61Labeling · Standard review	Approved	Label Letter
Jan 12, 2018	Supplement 62Labeling · Standard review	Approved	Letter Label
Apr 11, 2017	Supplement 59Labeling · Standard review	Approved	Label
Nov 5, 2015	Supplement 58Labeling · Standard review	Approved	Label Letter
Jul 31, 2015	Supplement 57Manufacturing · Priority review	Approved	None posted
May 28, 2015	Supplement 55Efficacy (new indication or use) · Priority review	Approved	Label Letter
Mar 6, 2015	Supplement 56Labeling · Standard review	Approved	Letter Label
May 30, 2013	Supplement 54Labeling · Standard review	Approved	Letter
Mar 7, 2013	Supplement 53Labeling · Standard review	Approved	Letter Label
Dec 10, 2012	Supplement 51Labeling · Standard review	Approved	Label Letter
Jul 11, 2011	Supplement 49Labeling	Approved	Letter
Jun 6, 2011	Supplement 50REMS	Approved	Letter
Nov 23, 2010	Supplement 47Labeling	Approved	Letter Label
Nov 23, 2010	Supplement 44Labeling	Approved	Letter Label
Nov 8, 2010	Supplement 48Labeling · Standard review	Approved	Letter Label
Jul 2, 2010	Supplement 46Labeling	Approved	Label Letter
Apr 22, 2010	Supplement 43Labeling	Approved	Label Letter
Apr 22, 2010	Supplement 42Labeling	Approved	Label Letter
Jan 25, 2010	Supplement 45Labeling	Approved	Label Letter
Oct 8, 2009	Supplement 41Labeling	Approved	Letter Label
Sep 24, 2009	Supplement 40Labeling · Standard review	Approved	Letter Label
Jan 29, 2009	Supplement 38Labeling · Standard review	Approved	Label
Mar 5, 2008	Supplement 37Labeling · Standard review	Approved	Letter Label
Mar 5, 2008	Supplement 36Labeling · Standard review	Approved	Letter Label
Jan 14, 2008	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 17, 2007	Supplement 34Labeling · Standard review	Approved	Letter Label
May 2, 2007	Supplement 31Labeling · Standard review	Approved	Letter Label
Jan 30, 2007	Supplement 29Efficacy (new indication or use)	Approved	Letter
Jan 12, 2007	Supplement 30Labeling · Standard review	Approved	Letter Label
Jan 9, 2007	Supplement 26Labeling · Standard review	Approved	Letter Label
Oct 19, 2006	Supplement 28Labeling · Standard review	Approved	Label
Jun 2, 2006	Supplement 24Efficacy (new indication or use)	Approved	Letter Label
Jun 2, 2006	Supplement 25Labeling · Standard review	Approved	Letter Label
Oct 7, 2005	Supplement 22Labeling · Standard review	Approved	Letter Label
Oct 7, 2005	Supplement 23Labeling · Standard review	Approved	Letter Label
Jun 30, 2005	Supplement 20Labeling · Standard review	Approved	Letter Label
Jun 30, 2005	Supplement 21Labeling · Standard review	Approved	Letter Label
Mar 11, 2005	Supplement 19Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jul 20, 2004	Supplement 17Labeling · Standard review	Approved	Letter Label
Oct 2, 2003	Supplement 15Labeling · Standard review	Approved	Label Letter
Apr 11, 2003	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 19, 2003	Supplement 14Labeling · Standard review	Approved	Letter Label
Jan 31, 2003	Supplement 12Labeling · Standard review	Approved	None posted
Jan 23, 2003	Supplement 5Labeling · Standard review	Approved	Label Letter
Jan 23, 2003	Supplement 7Labeling · Standard review	Approved	Letter Label
Jan 23, 2003	Supplement 8Labeling · Standard review	Approved	Label Letter
Jan 23, 2003	Supplement 9Labeling · Standard review	Approved	Letter Label
Jan 23, 2003	Supplement 10Labeling · Standard review	Approved	Label Letter
Aug 25, 2000	Supplement 4Labeling · Standard review	Approved	None posted
May 3, 2000	Supplement 2Labeling · Standard review	Approved	None posted
Mar 17, 2000	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 15, 1999	Original applicationNew molecular entity · Priority review	Approved	Review Letter

Show all 58

Identifiers

Application: NDA 21083
Drugs@FDA: Overview at FDA
Company: PF PRISM CV

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