ALEXION PHARM FDA Approval BLA 761108

BLA 761108

ALEXION PHARM

FDA Drug Application

Application #761108

Documents

Label2018-12-21
Letter2018-12-21
Review2019-01-18
Label2019-10-18
Medication Guide2019-10-18
Letter2019-10-22
Letter2020-05-01
Pediatric Other1900-01-01

Application Sponsors

BLA 761108ALEXION PHARM

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION300MG/30ML(10MG/ML)0ULTOMIRISRAVULIZUMAB-CWVZ

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2018-12-21PRIORITY
REMS; REMSSUPPL7AP2020-04-30N/A

Submissions Property Types

ORIG1Null40
SUPPL7Null7

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
        )

)

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