← FDA DRUG APPROVALS

FDA NDA · NDA219164

YUVIWEL

navepegritide

Sponsor: ASCENDIS

APPLICATION
NDA219164
TYPE
NDA
ORIGINAL APPROVAL
2026-02-27
LATEST ACTION
2026-02-27
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

YUVIWEL · ReferencePrescription
NAVEPEGRITIDE 2.8MG/VIAL · POWDER · SUBCUTANEOUS
YUVIWEL · ReferencePrescription
NAVEPEGRITIDE 5.5MG/VIAL · POWDER · SUBCUTANEOUS
YUVIWEL · ReferencePrescription
NAVEPEGRITIDE 1.3MG/VIAL · POWDER · SUBCUTANEOUS

Approval history

2026-02-27Type 1 - New Molecular Entity · Original · priority — Letter ↗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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