NOVARTIS FDA Approval NDA 022291

NDA 022291

NOVARTIS

FDA Drug Application

Application #022291

Documents

Letter2008-11-26
Letter2011-03-02
Letter2011-12-07
Letter2012-11-19
Letter2014-02-12
Letter2014-08-28
Letter2014-07-17
Letter2015-04-08
Label2011-12-06
Label2014-02-11
Label2014-04-28
Label2015-06-12
Review2009-01-14
Letter2010-03-09
Letter2014-04-28
Letter2015-06-12
Label2008-11-21
Label2011-03-04
Label2012-11-19
Label2014-08-27
Label2015-04-10
Summary Review2009-01-14
Label2016-10-17
Label2017-03-10
Letter2017-03-14
Label2017-07-10
Label2017-10-05
Letter2017-10-06
Pediatric Written Request2010-01-25
Pediatric Amendment 12011-11-23
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-07-25
Letter2018-07-26
Label2018-11-19
Medication Guide2018-11-19
Letter2018-12-07
Letter2020-04-29
Letter2020-04-30
Label2020-05-01
Medication Guide2020-05-01
Pediatric Written Request1900-01-01
Pediatric Amendment 11900-01-01
Label2021-02-04
Letter2021-02-04
Letter2021-04-28
Label2021-04-28
Letter2022-04-04
Label2022-04-05
Medication Guide2022-04-05
Letter2023-01-17
Letter2023-01-17
Label2023-01-19

Application Sponsors

NDA 022291NOVARTIS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Discontinued005

Application Products

001TABLET;ORALEQ 25MG ACID1PROMACTAELTROMBOPAG OLAMINE
002TABLET;ORALEQ 50MG ACID1PROMACTAELTROMBOPAG OLAMINE
003TABLET;ORALEQ 75MG ACID1PROMACTAELTROMBOPAG OLAMINE
004TABLET;ORALEQ 12.5MG ACID1PROMACTAELTROMBOPAG OLAMINE
005TABLET;ORALEQ 100MG ACID1PROMACTAELTROMBOPAG OLAMINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2008-11-20PRIORITY
REMS; REMSSUPPL3AP2010-03-05N/A
LABELING; LabelingSUPPL6AP2011-12-06UNKNOWN
EFFICACY; EfficacySUPPL8AP2012-11-16PRIORITY
LABELING; LabelingSUPPL10AP2014-02-10STANDARD
LABELING; LabelingSUPPL11AP2014-04-10STANDARD
EFFICACY; EfficacySUPPL12AP2014-08-26PRIORITY
REMS; REMSSUPPL13AP2014-07-16N/A
LABELING; LabelingSUPPL14AP2015-04-07STANDARD
EFFICACY; EfficacySUPPL15AP2015-06-11PRIORITY
LABELING; LabelingSUPPL16AP2016-10-12STANDARD
LABELING; LabelingSUPPL17AP2017-03-09STANDARD
LABELING; LabelingSUPPL18AP2017-07-05STANDARD
LABELING; LabelingSUPPL19AP2017-10-04901 REQUIRED
LABELING; LabelingSUPPL20AP2018-07-24STANDARD
EFFICACY; EfficacySUPPL21AP2018-11-16PRIORITY
LABELING; LabelingSUPPL26AP2020-04-28STANDARD
LABELING; LabelingSUPPL27AP2020-04-29STANDARD
LABELING; LabelingSUPPL31AP2021-02-03STANDARD
LABELING; LabelingSUPPL33AP2022-03-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2022-11-15N/A

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL6Null6
SUPPL8Null7
SUPPL10Null6
SUPPL11Null6
SUPPL12Null30
SUPPL13Null7
SUPPL14Null15
SUPPL15Null15
SUPPL16Null6
SUPPL17Null7
SUPPL18Null7
SUPPL19Orphan5
SUPPL20Null6
SUPPL21Null6
SUPPL26Null15
SUPPL27Null6
SUPPL31Null7
SUPPL33Null7

CDER Filings

NOVARTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22291
            [companyName] => NOVARTIS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/022291s033,207027s015lbl.pdf#page=35"]
            [products] => [{"drugName":"PROMACTA","activeIngredients":"ELTROMBOPAG OLAMINE","strength":"EQ 25MG ACID","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PROMACTA","activeIngredients":"ELTROMBOPAG OLAMINE","strength":"EQ 50MG ACID","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PROMACTA","activeIngredients":"ELTROMBOPAG OLAMINE","strength":"EQ 75MG ACID","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PROMACTA","activeIngredients":"ELTROMBOPAG OLAMINE","strength":"EQ 12.5MG ACID","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PROMACTA","activeIngredients":"ELTROMBOPAG OLAMINE","strength":"EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/31\/2022","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022291s033,207027s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2021","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022291s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2020","submission":"SUPPL-27","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022291s027,207027s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2020","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022291s027,207027s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2018","submission":"SUPPL-21","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022291s021lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022291s020,207027s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022291s019lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2017","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022291s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022291s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022291s016,207027s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2015","submission":"SUPPL-15","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022291s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2015","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022291s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2014","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022291s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022291Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022291s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022291s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2012","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022291s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2011","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022291s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2011","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022291s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2011","submission":"SUPPL-1","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022291s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022291lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROMACTA","submission":"ELTROMBOPAG OLAMINE","actionType":"EQ 25MG ACID","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PROMACTA","submission":"ELTROMBOPAG OLAMINE","actionType":"EQ 50MG ACID","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PROMACTA","submission":"ELTROMBOPAG OLAMINE","actionType":"EQ 75MG ACID","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PROMACTA","submission":"ELTROMBOPAG OLAMINE","actionType":"EQ 12.5MG ACID","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PROMACTA","submission":"ELTROMBOPAG OLAMINE","actionType":"EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-03-31
        )

)
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