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FDA NDA · NDA214103

OXLUMO

lumasiran

Sponsor: ALNYLAM PHARMS INC

APPLICATION
NDA214103
TYPE
NDA
ORIGINAL APPROVAL
2020-11-23
LATEST ACTION
2025-04-04
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

OXLUMO · ReferencePrescription
LUMASIRAN SODIUM EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-04-04Labeling · Supplement 6 · standard — Label ↗AP
2023-09-19Labeling · Supplement 4 · standard — Letter ↗AP
2022-10-06Efficacy · Supplement 3 · standard — Letter ↗AP
2020-11-23Type 1 - New Molecular Entity · Original · priority — Letter ↗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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