Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 70MG/ML | 0 | AIMOVIG | ERENUMAB-AOOE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-05-17 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-02-15 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-04-30 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-02-03 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-05-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2022-03-04 | N/A |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2022-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2022-08-15 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | TA | 2022-03-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 7 |
CDER Filings
AMGEN INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761077
[companyName] => AMGEN INC
[docInserts] => ["",""]
[products] => [{"drugName":"AIMOVIG","activeIngredients":"ERENUMAB-AOOE","strength":"70MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
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[originalApprovals] => [{"actionDate":"05\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761077s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761077Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761077Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/30\/2020","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761077s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761077Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"02\/15\/2020","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761077s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761077Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"10\/04\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761077s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761077Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"03\/11\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761077s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761077Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-04-30
)
)