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FDA NDA · NDA217388

WAINUA

eplontersen

Sponsor: ASTRAZENECA AB

APPLICATION
NDA217388
TYPE
NDA
ORIGINAL APPROVAL
2023-12-21
LATEST ACTION
2026-04-15
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

WAINUA (AUTOINJECTOR) · ReferencePrescription
EPLONTERSEN SODIUM EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) · SOLUTION · SUBCUTANEOUS
WAINUA · ReferencePrescription
EPLONTERSEN SODIUM EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-04-15Efficacy · Supplement 5 · standard — Letter ↗AP
2025-12-17Labeling · Supplement 6 · standard — Letter ↗AP
2025-04-18Labeling · Supplement 4 · standard — Letter ↗AP
2024-09-25Labeling · Supplement 2 · standard — Label ↗AP
2023-12-21Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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