CELGENE FDA Approval NDA 204026

Application #204026

Documents

Letter	2013-02-11
Letter	2013-11-18
Letter	2014-03-19
Letter	2015-04-24
Letter	2015-04-24
Letter	2015-04-24
Letter	2015-09-16
Letter	2015-10-28
Letter	2015-12-02
Letter	2016-07-01
Letter	2016-04-25
Letter	2016-07-01
Label	2013-02-08
Label	2014-03-19
Label	2015-04-28
Other	2013-02-12
Summary Review	2013-03-20
Letter	2014-09-16
Label	2015-04-28
Label	2015-04-28
Label	2016-07-05
Label	2016-07-05
Review	2013-03-20
Letter	2017-06-29
Label	2017-12-01
Letter	2017-12-01
Letter	2017-12-29
Label	2018-01-02
Label	2018-03-23
Medication Guide	2018-03-23
Letter	2018-03-28
Letter	2019-10-31
Label	2019-10-31
Medication Guide	2019-10-31
Label	2020-05-15
Medication Guide	2020-05-15
Medication Guide	2020-05-15
Letter	2020-05-15
Letter	2020-05-15
Letter	2020-11-25
Label	2020-11-25
Medication Guide	2020-11-25
Label	2020-12-03
Letter	2020-12-07
Label	2020-05-15
Letter	2021-08-09

Application Sponsors

NDA 204026

CELGENE

Marketing Status

Prescription	001
Prescription	002
Prescription	003
Prescription	004

Application Products

001	CAPSULE;ORAL	1MG	1	POMALYST	POMALIDOMIDE
002	CAPSULE;ORAL	2MG	1	POMALYST	POMALIDOMIDE
003	CAPSULE;ORAL	3MG	1	POMALYST	POMALIDOMIDE
004	CAPSULE;ORAL	4MG	1	POMALYST	POMALIDOMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2013-02-08	PRIORITY
REMS; REMS	SUPPL	2	AP	2013-11-15	N/A
LABELING; Labeling	SUPPL	3	AP	2014-03-13	STANDARD
REMS; REMS	SUPPL	4	AP	2014-09-12	N/A
LABELING; Labeling	SUPPL	5	AP	2015-04-23	UNKNOWN
EFFICACY; Efficacy	SUPPL	6	AP	2015-04-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-04-23	STANDARD
REMS; REMS	SUPPL	9	AP	2015-09-14	N/A
REMS; REMS	SUPPL	10	AP	2015-10-27	N/A
REMS; REMS	SUPPL	11	AP	2015-12-01	N/A
LABELING; Labeling	SUPPL	12	AP	2016-06-30	STANDARD
REMS; REMS	SUPPL	13	AP	2016-04-22	N/A
LABELING; Labeling	SUPPL	14	AP	2016-06-30	STANDARD
REMS; REMS	SUPPL	16	AP	2017-06-27	N/A
LABELING; Labeling	SUPPL	17	AP	2018-03-20	STANDARD
LABELING; Labeling	SUPPL	18	AP	2017-11-30	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-12-29	STANDARD
LABELING; Labeling	SUPPL	21	AP	2019-10-30	STANDARD
EFFICACY; Efficacy	SUPPL	23	AP	2020-05-14	PRIORITY
EFFICACY; Efficacy	SUPPL	24	AP	2020-05-14	PRIORITY
EFFICACY; Efficacy	SUPPL	27	AP	2020-11-20	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2020-12-03	STANDARD
REMS; REMS	SUPPL	29	AP	2021-08-05	N/A

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	6
SUPPL	5	Null	15
SUPPL	6	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	6
SUPPL	13	Null	15
SUPPL	14	Null	6
SUPPL	16	Orphan	5
SUPPL	17	Null	6
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	21	Null	7
SUPPL	23	Null	7
SUPPL	24	Null	15
SUPPL	27	Null	7
SUPPL	28	Null	7
SUPPL	29	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

CELGENE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204026
            [companyName] => CELGENE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/204026s023lbl.pdf#page=33"]
            [products] => [{"drugName":"POMALYST","activeIngredients":"POMALIDOMIDE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"POMALYST","activeIngredients":"POMALIDOMIDE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"POMALYST","activeIngredients":"POMALIDOMIDE","strength":"3MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"POMALYST","activeIngredients":"POMALIDOMIDE","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/14\/2020","submission":"SUPPL-23","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204026s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2019","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204026s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204026s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204026s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2017","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204026s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204026s012s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204026s012s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204026s005s006s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2015","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204026s005s006s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204026s005s006s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204026s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204026lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/08\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204026lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204026Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204026Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204026Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/14\/2020","submission":"SUPPL-24","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204026Orig1s024ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/14\/2020","submission":"SUPPL-23","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204026s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204026Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"10\/30\/2019","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204026s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204026Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"12\/29\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204026s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204026Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"11\/30\/2017","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204026s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204026Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"03\/20\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204026s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204026Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"06\/27\/2017","submission":"SUPPL-16","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204026Orig1s016ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204026s012s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204026Orig1s012,s014ltr.pdf\"}]","notes":">"},{"actionDate":"04\/22\/2016","submission":"SUPPL-13","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204026Orig1s013ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204026s012s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204026Orig1s012,s014ltr.pdf\"}]","notes":">"},{"actionDate":"12\/01\/2015","submission":"SUPPL-11","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204026Orig1s011ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/27\/2015","submission":"SUPPL-10","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204026Orig1s010ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/14\/2015","submission":"SUPPL-9","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204026Orig1s009ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/23\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204026s005s006s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/0204026Orig1s005,s006,s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/23\/2015","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204026s005s006s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/0204026Orig1s005,s006,s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/23\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204026s005s006s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/0204026Orig1s005,s006,s008ltr.pdf\"}]","notes":">"},{"actionDate":"09\/12\/2014","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204026Orig1s004ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/13\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204026s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204026Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"11\/15\/2013","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204026Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/03\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-14
        )

)

NDA 204026

CELGENE

FDA Drug Application

Application #204026

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

CELGENE