NDA 214103

ALNYLAM PHARMS INC

FDA Drug Application

Application #214103

Documents

• Letter: 2020-11-25
• Label: 2020-12-08
• Review: 2020-12-21
• Letter: 2022-10-07
• Label: 2022-10-11

Application Sponsors

NDA 214103

ALNYLAM PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;SUBCUTANEOUS

94.5MG/0.5ML

2

OXLUMO

LUMASIRAN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-11-23	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2022-10-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

TBD

CDER Filings

ALNYLAM PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214103
            [companyName] => ALNYLAM PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXLUMO","activeIngredients":"LUMASIRAN","strength":"94.5MG\/0.5ML","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214103Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-23
        )

)