Revlimid

NDA 21880, held by Bristol Myers Squibb. Lenalidomide.

As of Nov 14, 2026, NDA 21880 (Revlimid), held by Bristol Myers Squibb, was first approved by FDA on Dec 27, 2005, with 38 approved supplements and 0 published complete response letters.

First approved: Dec 27, 2005
Review: Priority
Supplements approved: 38
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with:

Multiple myeloma (MM), in combination with dexamethasone.
MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Previously treated follicular lymphoma (FL), in combination with a rituximab product.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 39 submissions below


May 28, 2019	Supplement 57Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 15, 2017	Supplement 51Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 22, 2017	Supplement 49Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 17, 2015	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 5, 2013	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 21, 2011	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 12, 2010	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 29, 2006	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 27, 2005	Original applicationNew molecular entity · Priority review	Approved	REMS Other Review Letter

Products

6 strengths and forms


Revlimid5MG · capsule;oral	Lenalidomide	RxReference drug
Revlimid10MG · capsule;oral	Lenalidomide	RxReference drug
Revlimid15MG · capsule;oral	Lenalidomide	RxReference drug
Revlimid25MG · capsule;oral	Lenalidomide	RxReference drug
Revlimid2.5MG · capsule;oral	Lenalidomide	RxReference drug
Revlimid20MG · capsule;oral	Lenalidomide	RxReference drug

All 39 submissions, including labeling and manufacturing supplements


Jul 22, 2026	Supplement 70Labeling · Standard review	Approved	Letter Label
Apr 27, 2026	Supplement 69REMS	Approved	Letter
Mar 24, 2023	Supplement 67REMS	Approved	Letter Label Medication Guide
May 24, 2022	Supplement 65Labeling · Standard review	Approved	Label Letter
Aug 31, 2021	Supplement 64Labeling · Standard review	Approved	Letter Label
Aug 5, 2021	Supplement 63REMS	Approved	Letter
Sep 24, 2020	Supplement 54REMS	Approved	Letter
Oct 30, 2019	Supplement 60Labeling · Standard review	Approved	Letter Label
May 28, 2019	Supplement 57Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 22, 2019	Supplement 56Labeling · Standard review	Approved	Letter Label
Dec 29, 2017	Supplement 55Labeling · Standard review	Approved	Label Letter
Nov 30, 2017	Supplement 53Labeling · Standard review	Approved	Letter Label
Nov 30, 2017	Supplement 52Labeling · Standard review	Approved	Letter Label
Sep 15, 2017	Supplement 51Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 27, 2017	Supplement 50REMS	Approved	Letter
Feb 22, 2017	Supplement 49Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 22, 2016	Supplement 47REMS	Approved	Letter
Dec 1, 2015	Supplement 46REMS	Approved	Letter
Oct 27, 2015	Supplement 45REMS	Approved	Letter
Sep 13, 2015	Supplement 44REMS	Approved	Letter
Feb 17, 2015	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 12, 2014	Supplement 40Labeling · Standard review	Approved	Label Letter
Sep 12, 2014	Supplement 39REMS	Approved	Label Letter
Dec 19, 2013	Supplement 36Manufacturing · Priority review	Approved	None posted
Nov 15, 2013	Supplement 35REMS	Approved	Letter
Nov 4, 2013	Supplement 38Labeling · Standard review	Approved	Letter Label
Jun 5, 2013	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 8, 2013	Supplement 33Labeling · Standard review	Approved	Letter Label
Feb 8, 2013	Supplement 29REMS	Approved	Letter Label
May 9, 2012	Supplement 31REMS	Approved	Letter Label
Mar 12, 2012	Supplement 28Labeling · Standard review	Approved	Letter Label
Dec 21, 2011	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 12, 2010	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 3, 2010	Supplement 13Labeling · Standard review	Approved	Label Letter
Feb 23, 2009	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 23, 2009	Supplement 16Labeling · Standard review	Approved	Letter Label
Feb 23, 2009	Supplement 6Labeling · Standard review	Approved	Letter Label
Jun 29, 2006	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 27, 2005	Original applicationNew molecular entity · Priority review	Approved	REMS Other Review Letter

Identifiers

Application: NDA 21880
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

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