NDA 212888

VIIV HLTHCARE

FDA Drug Application

Application #212888

Documents

• Letter: 2021-01-22
• Label: 2021-01-26
• Review: 2021-03-03
• Letter: 2022-02-01
• Label: 2022-02-03
• Letter: 2022-02-09
• Label: 2022-02-10
• Letter: 2022-03-24
• Label: 2022-03-25
• Letter: 2022-03-30
• Letter: 2022-03-30
• Label: 2022-03-30
• Label: 2022-03-30

Application Sponsors

NDA 212888

VIIV HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, FILM COATED	30MG	0	CABENUVA	CABOTEGRAVIR;RILPIVIRINE
002	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	600MG/3ML; 900MG/3ML	2	CABENUVA	CABOTEGRAVIR;RILPIVIRINE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2021-01-21	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-02-07	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2022-03-23	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2022-03-29	PRIORITY
EFFICACY; Efficacy	SUPPL	6	AP	2022-03-29	PRIORITY

Submissions Property Types

ORIG	1	Null	33
SUPPL	2	Null	7
SUPPL	3	Null	6
SUPPL	5	Null	6
SUPPL	6	Null	6

TE Codes

001	Prescription	TBD
002	Prescription	TBD

CDER Filings

VIIV HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212888
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABENUVA","activeIngredients":"CABOTEGRAVIR;RILPIVIRINE","strength":"400MG\/2ML; 600MG\/2ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"CABENUVA","activeIngredients":"CABOTEGRAVIR;RILPIVIRINE","strength":"600MG\/3ML; 900MG\/3ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/21\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212888s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212888s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212888Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-01-21
        )

)