VIIV HLTHCARE FDA Approval NDA 022128

NDA 022128

VIIV HLTHCARE

FDA Drug Application

Application #022128

Documents

Letter2007-08-07
Letter2008-11-28
Letter2009-11-27
Letter2010-06-03
Letter2011-10-25
Letter2012-08-15
Letter2014-03-28
Label2007-08-07
Label2009-11-23
Label2010-06-03
Label2013-02-06
Label2015-05-11
Letter2013-02-04
Letter2013-02-19
Letter2015-04-22
Label2011-10-25
Label2012-08-22
Label2013-02-20
Label2014-04-01
Review2007-10-05
Label2016-11-08
Review2017-10-26
Label2018-07-19
Medication Guide2018-07-19
Letter2018-07-20
Letter2020-11-03
Label2020-11-03
Medication Guide2020-11-03

Application Sponsors

NDA 022128VIIV HLTHCARE

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL150MG1SELZENTRYMARAVIROC
002TABLET;ORAL300MG1SELZENTRYMARAVIROC
003TABLET;ORAL25MG1SELZENTRYMARAVIROC
004TABLET;ORAL75MG1SELZENTRYMARAVIROC

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2007-08-06PRIORITY
EFFICACY; EfficacySUPPL2AP2009-11-20STANDARD
EFFICACY; EfficacySUPPL4AP2010-05-27STANDARD
LABELING; LabelingSUPPL7AP2011-10-21STANDARD
LABELING; LabelingSUPPL9AP2012-08-10901 REQUIRED
LABELING; LabelingSUPPL10AP2013-02-01STANDARD
LABELING; LabelingSUPPL11AP2013-02-14STANDARD
LABELING; LabelingSUPPL12AP2014-03-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2014-04-14PRIORITY
LABELING; LabelingSUPPL15AP2015-04-21STANDARD
EFFICACY; EfficacySUPPL17AP2016-11-04PRIORITY
LABELING; LabelingSUPPL18AP2018-07-18STANDARD
EFFICACY; EfficacySUPPL19AP2020-10-30PRIORITY

Submissions Property Types

ORIG1Null10
SUPPL2Null7
SUPPL4Null7
SUPPL7Null6
SUPPL9Null15
SUPPL10Null6
SUPPL11Null7
SUPPL12Null7
SUPPL13Null0
SUPPL15Null7
SUPPL17Null7
SUPPL18Null15
SUPPL19Null6

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22128
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/022128s018,208984s001lbl.pdf#page=43"]
            [products] => [{"drugName":"SELZENTRY","activeIngredients":"MARAVIROC","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SELZENTRY","activeIngredients":"MARAVIROC","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SELZENTRY","activeIngredients":"MARAVIROC","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SELZENTRY","activeIngredients":"MARAVIROC","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/18\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022128s018,208984s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2016","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208984_022128s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022128s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022128s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022128s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022128s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022128s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022128s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022128s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2011","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022128s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/27\/2010","submission":"SUPPL-4","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022128s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2009","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022128s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/06\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022128lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SELZENTRY","submission":"MARAVIROC","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SELZENTRY","submission":"MARAVIROC","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SELZENTRY","submission":"MARAVIROC","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SELZENTRY","submission":"MARAVIROC","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-07-18
        )

)
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