NDA 210922

ALNYLAM PHARMS INC

FDA Drug Application

Application #210922

Documents

• Label: 2018-08-10
• Letter: 2018-08-13
• Review: 2018-09-07
• Letter: 2019-05-07
• Label: 2019-05-13
• Letter: 2019-09-17
• Label: 2019-09-18
• Letter: 2020-04-20
• Label: 2020-04-20
• Letter: 2021-05-10
• Label: 2021-05-12
• Letter: 2022-10-04
• Label: 2022-10-07
• Letter: 2023-01-17
• Label: 2023-01-17

Application Sponsors

NDA 210922

ALNYLAM PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

EQ 10MG BASE/5ML (EQ 2MG BASE/ML)

1

ONPATTRO

PATISIRAN SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-08-10	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2019-09-16	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-04-17	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-05-06	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2023-01-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-10-04	STANDARD

Submissions Property Types

ORIG	1	Null	30
SUPPL	4	Null	6
SUPPL	7	Orphan	5
SUPPL	9	Null	6
SUPPL	12	Null	6
SUPPL	13	Orphan	5

CDER Filings

ALNYLAM PHARMS INC

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(
    [0] => Array
        (
            [ApplNo] => 210922
            [companyName] => ALNYLAM PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONPATTRO","activeIngredients":"PATISIRAN SODIUM","strength":"EQ 10MG BASE\/5ML (EQ 2MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/06\/2021","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/210922s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210922s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210922s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210922Orig1s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210922s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/10\/2018","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\\\/2018\\\/210922s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210922Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210922Orig1s000TOC.cfm\"}]","notes":">"}]
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            [actionDate] => 2021-05-06
        )

)