Documents
Application Sponsors
| BLA 125521 | ELI LILLY AND CO | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 80MG/ML | 0 | TALTZ | IXEKIZUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2016-03-22 | STANDARD |
| UNKNOWN; | SUPPL | 2 | AP | 2018-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-07-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2017-12-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2018-05-17 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2018-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2021-03-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2019-08-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2020-05-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2020-03-26 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2022-05-04 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2022-07-27 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 46 |
CDER Filings
ELI LILLY AND CO
cder:Array
(
[0] => Array
(
[ApplNo] => 125521
[companyName] => ELI LILLY AND CO
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125521s019lbl.pdf#page=19"]
[products] => [{"drugName":"TALTZ","activeIngredients":"IXEKIZUMAB","strength":"80MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-19","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125521s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2020","submission":"SUPPL-20","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125521s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2019","submission":"SUPPL-16","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125521s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2018","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125521s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2018","submission":"SUPPL-2","supplementCategories":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125521Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125521s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125521s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125521s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/22\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125521s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125521Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125521Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125521Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"03\/26\/2020","submission":"SUPPL-20","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125521s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125521Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"05\/29\/2020","submission":"SUPPL-19","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125521s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125521Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"08\/23\/2019","submission":"SUPPL-16","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125521s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125521Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"03\/16\/2018","submission":"SUPPL-11","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125521Orig1s011ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/17\/2018","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125521s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125521Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"12\/01\/2017","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125521s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125521Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/05\/2017","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125521s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125521Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"04\/19\/2018","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125521Orig1s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125521Orig1s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-05-29
)
)