Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 30MG/ML | 2 | HEMLIBRA | EMICIZUMAB |
| 002 | INJECTABLE;INJECTION | 60MG/0.4ML | 2 | HEMLIBRA | EMICIZUMAB |
| 003 | INJECTABLE;INJECTION | 105MG/0.7ML | 2 | HEMLIBRA | EMICIZUMAB |
| 004 | INJECTABLE;INJECTION | 150MG | 2 | HEMLIBRA | EMICIZUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2017-11-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2018-10-04 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2018-10-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-09-02 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2022-06-06 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Orphan | 5 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 13 | Orphan | 5 |
| SUPPL | 15 | Null | 6 |
CDER Filings
GENENTECH INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761083
[companyName] => GENENTECH INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/761083s002s004lbl.pdf#page=21"]
[products] => [{"drugName":"HEMLIBRA","activeIngredients":"EMICIZUMAB","strength":"30MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"HEMLIBRA","activeIngredients":"EMICIZUMAB","strength":"60MG\/0.4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"HEMLIBRA","activeIngredients":"EMICIZUMAB","strength":"105MG\/0.7ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"HEMLIBRA","activeIngredients":"EMICIZUMAB","strength":"150MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"10\/04\/2018","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761083s002s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761083s002s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761083s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761083s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761083Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761083Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/04\/2018","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761083s002s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761083Orig1s002,761083Orig1s004Ltr.pdf\"}]","notes":">"},{"actionDate":"10\/04\/2018","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761083s002s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761083Orig1s002,761083Orig1s004Ltr.pdf\"}]","notes":">"}]
[actionDate] => 2018-10-04
)
)