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FDA NDA · NDA212194

GIVLAARI

givosiran sodium

Sponsor: ALNYLAM PHARMS INC

APPLICATION
NDA212194
TYPE
NDA
ORIGINAL APPROVAL
2019-11-20
LATEST ACTION
2024-04-29
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

GIVLAARI · ReferencePrescription
GIVOSIRAN SODIUM EQ 189MG BASE/ML (EQ 189MG BASE/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2024-04-29Labeling · Supplement 7 · standard — Letter ↗AP
2023-02-10Labeling · Supplement 5 · standard — Letter ↗AP
2021-10-28Labeling · Supplement 4 · standard — Letter ↗AP
2019-11-20Type 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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