Documents
Application Sponsors
| NDA 208716 | ELI LILLY AND CO | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 50MG | 1 | VERZENIO | ABEMACICLIB |
| 002 | TABLET;ORAL | 100MG | 1 | VERZENIO | ABEMACICLIB |
| 003 | TABLET;ORAL | 150MG | 1 | VERZENIO | ABEMACICLIB |
| 004 | TABLET;ORAL | 200MG | 1 | VERZENIO | ABEMACICLIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2017-09-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-09-09 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2020-03-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-10-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2021-10-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2021-10-12 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 7 |
CDER Filings
ELI LILLY AND CO
cder:Array
(
[0] => Array
(
[ApplNo] => 208716
[companyName] => ELI LILLY AND CO
[docInserts] => ["",""]
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[supplements] => [{"actionDate":"03\/30\/2020","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208716s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208716Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/09\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208716s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208716Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"08\/17\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208716s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208716Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-03-30
)
)