BLA 761119

Lundbeck Seattle BioPharmaceuticals, Inc.

FDA Drug Application

Application #761119

Documents

• Label: 2020-02-24
• Letter: 2020-02-24
• Review: 2020-03-23
• Letter: 2021-09-28
• Label: 2021-09-29
• Letter: 2022-10-24
• Label: 2022-10-26

Application Sponsors

BLA 761119

Lundbeck Seattle BioPharmaceuticals, Inc.

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

VYEPTI

EPTINEZUMAB-JJMR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-09-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-10-21	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7
SUPPL	6	Null	15

CDER Filings

Lundbeck Seattle BioPharmaceuticals, Inc.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761119
            [companyName] => Lundbeck Seattle BioPharmaceuticals, Inc.
            [docInserts] => ["",""]
            [products] => [{"drugName":"VYEPTI","activeIngredients":"EPTINEZUMAB-JJMR","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/21\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761119s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761119s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761119Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/761119Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-02-21
        )

)