BLA 761181

REGENERON PHARMACEUTICALS

FDA Drug Application

Application #761181

Documents

• Letter: 2021-02-16
• Label: 2021-02-16
• Review: 2021-03-11

Application Sponsors

BLA 761181

REGENERON PHARMACEUTICALS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION; INJECTION	345MG/2.3ML	0	EVKEEZA	EVINACUMAB-DGNB
002	SOLUTION; INJECTION	1200MG/8ML	0	EVKEEZA	EVINACUMAB-DGNB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-02-11

PRIORITY

Submissions Property Types

ORIG

1

Null

30

CDER Filings

REGENERON PHARMACEUTICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761181
            [companyName] => REGENERON PHARMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVKEEZA","activeIngredients":"EVINACUMAB-DGNB","strength":"345MG\/2.3ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"EVKEEZA","activeIngredients":"EVINACUMAB-DGNB","strength":"1200MG\/8ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/11\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761181s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/11\/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\\\/761181s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761181Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-02-11
        )

)