BLA 761235

GENENTECH INC

FDA Drug Application

Application #761235

Documents

• Letter: 2022-01-31
• Label: 2022-02-01
• Review: 2022-02-28
• Label: 2023-01-30
• Letter: 2023-01-30

Application Sponsors

BLA 761235

GENENTECH INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INTRAVITREAL

120MG/ML

0

FARICIMAB

VABYSMO

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-01-28

PRIORITY

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GENENTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761235
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FARICIMAB","activeIngredients":"VABYSMO","strength":"120MG\/ML","dosageForm":"INJECTABLE; INTRAVITREAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/28\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761235s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761235s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761235Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-01-28
        )

)