Documents
Application Sponsors
| BLA 125477 | ELI LILLY AND CO | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 100MG/10ML | 0 | CYRAMZA | RAMUCIRUMAB |
| 002 | INJECTABLE;INJECTION | 500MG/50ML | 0 | CYRAMZA | RAMUCIRUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-04-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2014-11-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2014-12-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2015-04-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2019-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2018-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2018-11-26 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2019-07-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 34 | AP | 2020-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2019-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2020-02-20 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2020-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2021-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2022-03-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 34 | Null | 7 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 42 | Null | 7 |
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
)
)