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FDA NDA · NDA210922

ONPATTRO

patisiran

Sponsor: ALNYLAM PHARMS INC

APPLICATION
NDA210922
TYPE
NDA
ORIGINAL APPROVAL
2018-08-10
LATEST ACTION
2023-01-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ONPATTRO · ReferencePrescription
PATISIRAN SODIUM EQ 10MG BASE/5ML (EQ 2MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-01-13Efficacy · Supplement 12 · standard — Letter ↗AP
2022-10-03Labeling · Supplement 13 · standard — Letter ↗AP
2021-05-06Labeling · Supplement 9 · standard — Letter ↗AP
2020-04-17Labeling · Supplement 7 · standard — Letter ↗AP
2019-09-16Labeling · Supplement 4 · standard — Letter ↗AP
2019-05-06Labeling · Supplement 1 · standard — Letter ↗AP
2018-08-10Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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