EISAI INC FDA Approval NDA 201532

NDA 201532

EISAI INC

FDA Drug Application

Application #201532

Documents

Letter2010-11-18
Letter2013-08-23
Letter2014-08-04
Letter2014-12-24
Letter2015-10-28
Letter2016-01-29
Label2015-11-04
Label2016-01-28
Review2011-01-03
Summary Review2011-02-17
Letter2012-02-23
Label2010-11-15
Label2012-02-22
Label2013-08-27
Label2014-08-04
Label2015-01-09
Letter2016-10-20
Label2016-10-27
Letter2021-02-23
Letter2021-10-01
Label2022-01-05
Letter2022-09-14
Label2022-09-14

Application Sponsors

NDA 201532EISAI INC

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS1MG/2ML (0.5MG/ML)1HALAVENERIBULIN MESYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2010-11-15PRIORITY
LABELING; LabelingSUPPL4AP2012-02-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2012-11-07PRIORITY
LABELING; LabelingSUPPL6AP2013-08-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2013-09-27PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2013-10-24PRIORITY
LABELING; LabelingSUPPL9AP2014-08-01STANDARD
LABELING; LabelingSUPPL10AP2014-12-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2015-04-10PRIORITY
LABELING; LabelingSUPPL13AP2015-10-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2015-11-18PRIORITY
EFFICACY; EfficacySUPPL15AP2016-01-28PRIORITY
LABELING; LabelingSUPPL16AP2016-10-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2016-07-21PRIORITY
LABELING; LabelingSUPPL20TA2020-08-21STANDARD
LABELING; LabelingSUPPL21AP2021-09-30STANDARD
EFFICACY; EfficacySUPPL23AP2022-09-13PRIORITY

Submissions Property Types

ORIG1Null40
SUPPL4Null7
SUPPL5Null0
SUPPL6Null15
SUPPL7Null0
SUPPL8Null0
SUPPL9Null15
SUPPL10Null6
SUPPL12Null0
SUPPL13Null15
SUPPL14Null0
SUPPL15Null6
SUPPL16Null7
SUPPL17Null0
SUPPL20Orphan5
SUPPL21Null15
SUPPL23Null15

CDER Filings

EISAI INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201532
            [companyName] => EISAI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALAVEN","activeIngredients":"ERIBULIN MESYLATE","strength":"1MG\/2ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/19\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201532s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2016","submission":"SUPPL-15","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201532s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201532s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201532s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201532s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2013","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201532s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201532s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/201532lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/15\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/201532lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/201532s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/201532s000_halaven_TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/201532Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/21\/2016","submission":"SUPPL-17","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201532s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201532Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"01\/28\/2016","submission":"SUPPL-15","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201532s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201532Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"11\/18\/2015","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/27\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201532s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201532s013ltr.pdf\"}]","notes":">"},{"actionDate":"04\/10\/2015","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/19\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201532s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201532Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"08\/01\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201532s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201532Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/24\/2013","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/27\/2013","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/22\/2013","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201532s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/201532Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"11\/07\/2012","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/17\/2012","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201532s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201532s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2016-10-19
        )

)
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