BLA 761195

ARGENX BV

FDA Drug Application

Application #761195

Documents

• Label: 2021-12-19
• Letter: 2021-12-21
• Review: 2022-01-19

Application Sponsors

BLA 761195

ARGENX BV

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

400MG

0

VYVGART

EFGARTIGIMOD ALFA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-12-17

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

ARGENX BV

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(
    [0] => Array
        (
            [ApplNo] => 761195
            [companyName] => ARGENX BV
            [docInserts] => ["",""]
            [products] => [{"drugName":"VYVGART","activeIngredients":"EFGARTIGIMOD ALFA","strength":"400MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761195s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761195s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761195Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-17
        )

)