NDA 208573

ABBVIE INC

FDA Drug Application

Application #208573

Documents

• Label: 2016-04-11
• Summary Review: 2016-05-19
• Letter: 2016-04-11
• Review: 2016-05-19
• Label: 2017-12-26
• Label: 2018-06-08
• Label: 2018-06-08
• Letter: 2018-06-14
• Letter: 2018-06-14
• Label: 2018-09-11
• Label: 2018-09-11
• Letter: 2018-09-12
• Letter: 2018-09-12
• Label: 2018-11-21
• Letter: 2018-12-12
• Label: 2019-05-15
• Letter: 2019-05-16
• Letter: 2019-07-26
• Letter: 2019-07-26
• Letter: 2019-07-26
• Label: 2019-07-29
• Label: 2019-07-29
• Label: 2019-07-29
• Medication Guide: 2019-07-29
• Medication Guide: 2019-07-29
• Medication Guide: 2019-07-29
• Review: 2019-09-30
• Letter: 2020-06-02
• Label: 2020-06-02
• Medication Guide: 2020-06-02
• Letter: 2020-06-15
• Label: 2020-06-26
• Label: 2020-10-16
• Label: 2020-10-16
• Medication Guide: 2020-10-16
• Letter: 2020-10-20
• Letter: 2020-10-20
• Letter: 2020-11-20
• Label: 2020-11-23
• Medication Guide: 2020-12-02
• Review: 2020-12-09
• Review: 2020-12-09
• Label: 2021-10-05
• Letter: 2021-10-06
• Letter: 2021-10-25
• Label: 2021-10-25
• Medication Guide: 2021-10-25
• Letter: 2022-06-16
• Label: 2022-06-16

Application Sponsors

NDA 208573

ABBVIE INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	10MG	1	VENCLEXTA	VENETOCLAX
002	TABLET;ORAL	50MG	1	VENCLEXTA	VENETOCLAX
003	TABLET;ORAL	100MG	1	VENCLEXTA	VENETOCLAX

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2016-04-11	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2017-12-20	PRIORITY
EFFICACY; Efficacy	SUPPL	4	AP	2018-06-08	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2018-06-08	PRIORITY
EFFICACY; Efficacy	SUPPL	7	AP	2018-09-07	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	2018-11-21	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2018-09-07	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-07-25	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2019-05-15	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2019-07-25	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-07-25	STANDARD
LABELING; Labeling	SUPPL	17	TA	2019-12-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-05-29	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2020-10-16	PRIORITY
EFFICACY; Efficacy	SUPPL	21	AP	2020-10-16	PRIORITY
LABELING; Labeling	SUPPL	23	AP	2020-11-19	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	2021-10-04	STANDARD
LABELING; Labeling	SUPPL	26	AP	2021-10-22	STANDARD
LABELING; Labeling	SUPPL	27	AP	2022-06-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	6
SUPPL	5	Null	6
SUPPL	7	Null	6
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	14	Orphan	5
SUPPL	15	Null	15
SUPPL	17	Orphan	5
SUPPL	18	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	30
SUPPL	23	Null	15
SUPPL	24	Null	6
SUPPL	26	Null	15
SUPPL	27	Null	15

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208573
            [companyName] => ABBVIE INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/208573s018lbl.pdf#page=46"]
            [products] => [{"drugName":"VENCLEXTA","activeIngredients":"VENETOCLAX","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VENCLEXTA","activeIngredients":"VENETOCLAX","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VENCLEXTA","activeIngredients":"VENETOCLAX","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/12\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208573Orig1s017Lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208573s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208573s011s014s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208573s011s014s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208573s011s014s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2019","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208573s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2018","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208573s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208573Orig1s007s010lblrpl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2018","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208573Orig1s007s010lblrpl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208573s004s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2018","submission":"SUPPL-4","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208573s004s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2017","submission":"SUPPL-3","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208573s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208573s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/11\/2016","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\\\/2016\\\/208573s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208573Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208573Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208573Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208573s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208573Orig1s018replacementltr.pdf\"}]","notes":">"},{"actionDate":"06\/12\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208573Orig1s017Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208573Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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            [actionDate] => 2020-06-12
        )

)