NDA 212194

ALNYLAM PHARMS INC

FDA Drug Application

Application #212194

Documents

• Label: 2019-11-20
• Letter: 2019-11-22
• Review: 2019-12-12
• Letter: 2021-10-29
• Label: 2021-10-29

Application Sponsors

NDA 212194

ALNYLAM PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;SUBCUTANEOUS

EQ 189MG BASE/ML (EQ 189MG BASE/ML)

1

GIVLAARI

GIVOSIRAN SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-11-20	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2021-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	4	Null	31

CDER Filings

ALNYLAM PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212194
            [companyName] => ALNYLAM PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GIVLAARI","activeIngredients":"GIVOSIRAN SODIUM","strength":"EQ 189MG BASE\/ML (EQ 189MG BASE\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/20\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/0212194s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/0212194s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212194Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212194Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-11-20
        )

)