EISAI INC FDA Approval BLA 761269

BLA 761269

EISAI INC

FDA Drug Application

Application #761269

Documents

Letter2023-01-06
Summary Review2023-01-06
Label2023-01-06
Medication Guide2023-01-09

Application Sponsors

BLA 761269EISAI INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION500MG/5ML2LEQEMBILECANEMAB-IRMB
002INJECTABLE;INJECTION200MG/2ML2LEQEMBILECANEMAB-IRMB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2023-01-06PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

EISAI INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761269
            [companyName] => EISAI INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/761269Orig1s000lbl.pdf#page=16"]
            [products] => [{"drugName":"LEQEMBI","activeIngredients":"LECANEMAB-IRMB","strength":"500MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"LEQEMBI","activeIngredients":"LECANEMAB-IRMB","strength":"200MG\/2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/06\/2023","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/761269Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/06\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/761269Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2023\\\/761269Orig1s000ltr.pdf\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/summary_review\\\/2023\\\/761269Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2023-01-06
        )

)

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