BLA 761310

IMMUNOGEN INC

FDA Drug Application

Application #761310

Documents

• Label: 2022-11-14
• Letter: 2022-11-15
• Review: 2022-12-07

Application Sponsors

BLA 761310

IMMUNOGEN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100mg/20mL single-dose vial

0

MIRVETUXIMAB SORAVTANSINE

MIRVETUXIMAB SORAVTANSINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-11-14

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

IMMUNOGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761310
            [companyName] => IMMUNOGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELAHERE","activeIngredients":"MIRVETUXIMAB SORAVTANSINE-GYNX","strength":"100mg\/20mL single-dose vial","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/14\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761310s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/14\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761310s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761310Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-11-14
        )

)