NDA 021880

CELGENE

FDA Drug Application

Application #021880

Documents

• Letter: 2010-08-09
• Letter: 2009-03-03
• Letter: 2011-12-28
• Letter: 2012-03-14
• Letter: 2013-02-12
• Letter: 2013-11-18
• Letter: 2013-11-07
• Letter: 2014-09-16
• Letter: 2015-09-15
• Letter: 2015-10-29
• Letter: 2016-04-26
• Label: 2010-08-10
• Label: 2009-02-24
• Label: 2010-10-19
• Label: 2011-12-23
• Label: 2013-02-12
• Label: 2014-09-19
• Label: 2015-02-24
• Review: 2006-02-08
• Other Important Information from FDA: 2005-12-28
• Other: 2010-08-16
• Letter: 2006-01-06
• Letter: 2006-07-13
• Letter: 2009-03-03
• Letter: 2009-03-03
• Letter: 2010-10-19
• Letter: 2012-05-11
• Letter: 2013-02-12
• Letter: 2013-06-06
• Letter: 2014-09-16
• Letter: 2015-02-19
• Letter: 2015-12-02
• Label: 2005-12-28
• Label: 2006-07-03
• Label: 2009-02-24
• Label: 2009-02-24
• Label: 2012-03-12
• Label: 2012-05-10
• Label: 2013-02-12
• Label: 2013-06-05
• Label: 2013-11-04
• Label: 2014-09-19
• Label: 2017-02-22
• Letter: 2017-02-23
• Letter: 2017-06-29
• Label: 2017-09-18
• Letter: 2017-09-19
• Label: 2017-11-30
• Label: 2017-11-30
• Letter: 2017-12-01
• Letter: 2017-12-01
• Letter: 2017-12-29
• Label: 2018-01-02
• Medication Guide: 2018-01-02
• Label: 2019-01-23
• Medication Guide: 2019-01-23
• Letter: 2019-02-13
• Label: 2019-05-28
• Medication Guide: 2019-05-28
• Letter: 2019-06-04
• Letter: 2019-10-31
• Label: 2019-10-31
• Medication Guide: 2019-10-31
• Letter: 2020-09-25
• Letter: 2021-08-09
• Letter: 2021-09-01
• Label: 2021-09-07
• Medication Guide: 2021-09-07
• Label: 2022-05-25
• Medication Guide: 2022-05-25
• Letter: 2022-05-25

Application Sponsors

NDA 021880

CELGENE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	CAPSULE;ORAL	5MG	1	REVLIMID	LENALIDOMIDE
002	CAPSULE;ORAL	10MG	1	REVLIMID	LENALIDOMIDE
003	CAPSULE;ORAL	15MG	1	REVLIMID	LENALIDOMIDE
004	CAPSULE;ORAL	25MG	1	REVLIMID	LENALIDOMIDE
005	CAPSULE;ORAL	2.5MG	1	REVLIMID	LENALIDOMIDE
006	CAPSULE;ORAL	20MG	1	REVLIMID	LENALIDOMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2005-12-27	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2009-02-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	2010-08-03	STANDARD
LABELING; Labeling	SUPPL	16	AP	2009-02-23	STANDARD
LABELING; Labeling	SUPPL	17	AP	2009-02-23	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2010-10-12	STANDARD
EFFICACY; Efficacy	SUPPL	23	AP	2011-12-21	STANDARD
LABELING; Labeling	SUPPL	28	AP	2012-03-12	STANDARD
REMS; REMS	SUPPL	29	AP	2013-02-08	N/A
REMS; REMS	SUPPL	31	AP	2012-05-09	N/A
LABELING; Labeling	SUPPL	33	AP	2013-02-08	STANDARD
EFFICACY; Efficacy	SUPPL	34	AP	2013-06-05	PRIORITY
REMS; REMS	SUPPL	35	AP	2013-11-15	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2013-12-19	PRIORITY
LABELING; Labeling	SUPPL	38	AP	2013-11-04	STANDARD
REMS; REMS	SUPPL	39	AP	2014-09-12	N/A
LABELING; Labeling	SUPPL	40	AP	2014-09-12	STANDARD
EFFICACY; Efficacy	SUPPL	41	AP	2015-02-17	STANDARD
REMS; REMS	SUPPL	44	AP	2015-09-13	N/A
REMS; REMS	SUPPL	45	AP	2015-10-27	N/A
REMS; REMS	SUPPL	46	AP	2015-12-01	N/A
REMS; REMS	SUPPL	47	AP	2016-04-22	N/A
EFFICACY; Efficacy	SUPPL	49	AP	2017-02-22	PRIORITY
REMS; REMS	SUPPL	50	AP	2017-06-27	N/A
EFFICACY; Efficacy	SUPPL	51	AP	2017-09-15	PRIORITY
LABELING; Labeling	SUPPL	52	AP	2017-11-30	STANDARD
LABELING; Labeling	SUPPL	53	AP	2017-11-30	STANDARD
REMS; REMS	SUPPL	54	AP	2020-09-24	N/A
LABELING; Labeling	SUPPL	55	AP	2017-12-29	STANDARD
LABELING; Labeling	SUPPL	56	AP	2019-01-22	STANDARD
EFFICACY; Efficacy	SUPPL	57	AP	2019-05-28	PRIORITY
LABELING; Labeling	SUPPL	60	AP	2019-10-30	STANDARD
REMS; REMS	SUPPL	63	AP	2021-08-05	N/A
LABELING; Labeling	SUPPL	64	AP	2021-08-31	STANDARD
LABELING; Labeling	SUPPL	65	AP	2022-05-24	STANDARD

Submissions Property Types

ORIG	1	Null	10
SUPPL	13	Null	7
SUPPL	18	Null	7
SUPPL	23	Null	7
SUPPL	28	Null	7
SUPPL	29	Null	15
SUPPL	31	Null	7
SUPPL	33	Null	15
SUPPL	34	Null	7
SUPPL	35	Null	15
SUPPL	36	Null	14
SUPPL	38	Null	6
SUPPL	39	Null	6
SUPPL	40	Null	6
SUPPL	41	Null	7
SUPPL	44	Null	15
SUPPL	45	Null	6
SUPPL	46	Null	7
SUPPL	47	Null	7
SUPPL	49	Null	7
SUPPL	50	Null	31
SUPPL	51	Null	15
SUPPL	52	Null	6
SUPPL	53	Null	6
SUPPL	54	Null	7
SUPPL	55	Null	6
SUPPL	56	Null	6
SUPPL	57	Null	7
SUPPL	60	Null	15
SUPPL	63	Null	6
SUPPL	64	Null	6
SUPPL	65	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

CELGENE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21880
            [companyName] => CELGENE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021880s060lbl.pdf#page=49"]
            [products] => [{"drugName":"REVLIMID","activeIngredients":"LENALIDOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"REVLIMID","activeIngredients":"LENALIDOMIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"REVLIMID","activeIngredients":"LENALIDOMIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"REVLIMID","activeIngredients":"LENALIDOMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"REVLIMID","activeIngredients":"LENALIDOMIDE","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"REVLIMID","activeIngredients":"LENALIDOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/30\/2019","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021880s060lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2019","submission":"SUPPL-57","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021880s057lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2019","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021880s056lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2017","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021880s055lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2017","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021880s052s053lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2017","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021880s052s053lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2017","submission":"SUPPL-51","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021880s051lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2017","submission":"SUPPL-49","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021880s049lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2015","submission":"SUPPL-41","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021880s041lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2015","submission":"SUPPL-41","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021880s041lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2014","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021880s039s040lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2014","submission":"SUPPL-39","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021880s039s040lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2013","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021880s038lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2013","submission":"SUPPL-34","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021880s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2013","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021880s029s033lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2013","submission":"SUPPL-29","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021880s029s033lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2012","submission":"SUPPL-31","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021880s031lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2012","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021880s028lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2011","submission":"SUPPL-23","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021880s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2010","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021880s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2010","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021880s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2010","submission":"SUPPL-13","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021880s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2009","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021880s006s016s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2009","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021880s006s016s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2009","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021880s006s016s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2006","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021880s001.pdf\"}]","notes":""},{"actionDate":"12\/27\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021880lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"REVLIMID","submission":"LENALIDOMIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REVLIMID","submission":"LENALIDOMIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REVLIMID","submission":"LENALIDOMIDE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REVLIMID","submission":"LENALIDOMIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REVLIMID","submission":"LENALIDOMIDE","actionType":"2.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REVLIMID","submission":"LENALIDOMIDE","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-30
        )

)