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FDA NDA · NDA215515

AMVUTTRA

vutrisiran

Sponsor: ALNYLAM PHARMS INC

APPLICATION
NDA215515
TYPE
NDA
ORIGINAL APPROVAL
2022-06-13
LATEST ACTION
2025-03-20
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

AMVUTTRA · ReferencePrescription
VUTRISIRAN SODIUM EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-03-20Efficacy · Supplement 6 · priority — Letter ↗AP
2025-03-11Labeling · Supplement 5 · standard — Letter ↗AP
2023-02-16Labeling · Supplement 2 · standard — Letter ↗AP
2022-06-13Type 1 - New Molecular Entity · Original · standard — 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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