BLA 761107

NOVIMMUNE S.A.

FDA Drug Application

Application #761107

Documents

• Letter: 2018-11-20
• Label: 2018-11-21
• Review: 2018-12-17

Application Sponsors

BLA 761107

NOVIMMUNE S.A.

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	10MG/2ML	0	GAMIFANT	EMAPALUMAB-LZSG
002	INJECTABLE;INJECTION	50MG/10ML	0	GAMIFANT	EMAPALUMAB-LZSG
003	INJECTABLE;INJECTION	100MG/20ML	0	GAMIFANT	EMAPALUMAB-LZSG

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-11-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2020-06-26	N/A

Submissions Property Types

ORIG

1

Null

15

CDER Filings

NOVIMMUNE S.A.

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    [0] => Array
        (
            [ApplNo] => 761107
            [companyName] => NOVIMMUNE S.A.
            [docInserts] => ["",""]
            [products] => [{"drugName":"GAMIFANT","activeIngredients":"EMAPALUMAB-LZSG","strength":"10MG\/2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GAMIFANT","activeIngredients":"EMAPALUMAB-LZSG","strength":"50MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/20\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761107s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761107s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761107Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761107Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-11-20
        )

)