Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 300MG/30ML(10MG/ML) | 0 | ULTOMIRIS | RAVULIZUMAB-CWVZ |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-12-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2020-10-09 | STANDARD |
| REMS; REMS | SUPPL | 7 | AP | 2020-04-30 | N/A |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2021-06-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 2021-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2022-01-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2022-07-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2022-04-27 | STANDARD |
| REMS; REMS | SUPPL | 24 | AP | 2021-11-22 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 15 |
CDER Filings
ALEXION PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 761108
[companyName] => ALEXION PHARM
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761108s001lbl.pdf#page=29"]
[products] => [{"drugName":"ULTOMIRIS","activeIngredients":"RAVULIZUMAB-CWVZ","strength":"300MG\/30ML(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/18\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761108s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761108s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761108s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761108Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761108Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/30\/2020","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761108Orig1s007ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761108s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761108Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-04-30
)
)