ELI LILLY AND CO FDA Approval BLA 125477

BLA 125477

ELI LILLY AND CO

FDA Drug Application

Application #125477

Documents

Letter2014-12-15
Letter2015-04-27
Label2014-04-21
Label2015-04-24
Summary Review2014-05-16
Letter2014-04-22
Letter2014-11-06
Label2014-11-05
Label2014-12-12
Review2014-05-16
Label2018-08-15
Letter2018-08-24
Letter2018-11-27
Letter2019-05-14
Letter2019-08-01
Label2019-08-02
Letter2019-11-08
Letter2020-02-21
Label2020-02-21
Letter2020-06-02
Label2020-06-09
Letter2020-07-07
Label2020-07-08
Letter2021-06-16
Label2021-06-17
Label2022-03-23
Letter2022-03-23

Application Sponsors

BLA 125477ELI LILLY AND CO

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION100MG/10ML0CYRAMZARAMUCIRUMAB
002INJECTABLE;INJECTION500MG/50ML0CYRAMZARAMUCIRUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2014-04-21PRIORITY
EFFICACY; EfficacySUPPL2AP2014-11-05STANDARD
EFFICACY; EfficacySUPPL7AP2014-12-12PRIORITY
EFFICACY; EfficacySUPPL11AP2015-04-24STANDARD
EFFICACY; EfficacySUPPL29AP2019-05-10STANDARD
LABELING; LabelingSUPPL30AP2018-08-14STANDARD
LABELING; LabelingSUPPL31AP2018-11-26STANDARD
LABELING; LabelingSUPPL33AP2019-07-31STANDARD
EFFICACY; EfficacySUPPL34AP2020-05-29STANDARD
LABELING; LabelingSUPPL35AP2019-11-05STANDARD
LABELING; LabelingSUPPL36AP2020-02-20STANDARD
LABELING; LabelingSUPPL37AP2020-07-06STANDARD
LABELING; LabelingSUPPL39AP2021-06-15STANDARD
LABELING; LabelingSUPPL42AP2022-03-22STANDARD

Submissions Property Types

ORIG1Orphan5
SUPPL2Null6
SUPPL7Null15
SUPPL11Null15
SUPPL29Null15
SUPPL30Null6
SUPPL31Null7
SUPPL33Null7
SUPPL34Null7
SUPPL35Null6
SUPPL36Null6
SUPPL37Null6
SUPPL39Null6
SUPPL42Null7

CDER Filings

ELI LILLY AND CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125477
            [companyName] => ELI LILLY AND CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYRAMZA","activeIngredients":"RAMUCIRUMAB","strength":"100MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CYRAMZA","activeIngredients":"RAMUCIRUMAB","strength":"500MG\/50ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/06\/2020","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125477s037lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2020","submission":"SUPPL-34","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125477s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2020","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125477s036lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125477s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125477s030lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2015","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125477s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2014","submission":"SUPPL-7","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125477s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2014","submission":"SUPPL-2","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125477s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125477lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/21\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125477lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125477Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125477Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125477Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/06\/2020","submission":"SUPPL-37","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125477s037lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125477Orig1s037ltr.pdf\"}]","notes":">"},{"actionDate":"02\/20\/2020","submission":"SUPPL-36","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125477s036lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125477Orig1s036ltr.pdf\"}]","notes":">"},{"actionDate":"11\/05\/2019","submission":"SUPPL-35","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125477Orig1s035ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/29\/2020","submission":"SUPPL-34","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125477s034lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125477Orig1s034ltr.pdf\"}]","notes":">"},{"actionDate":"07\/31\/2019","submission":"SUPPL-33","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125477s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125477Orig1s033ltr.pdf\"}]","notes":">"},{"actionDate":"11\/26\/2018","submission":"SUPPL-31","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125477Orig1s031ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/14\/2018","submission":"SUPPL-30","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125477s030lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"05\/10\/2019","submission":"SUPPL-29","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125477Orig1s029ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2015","submission":"SUPPL-11","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125477s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125477Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"12\/12\/2014","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125477s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125477Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/05\/2014","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125477s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125477Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-07-06
        )

)

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