← FDA DRUG APPROVALS

FDA NDA · NDA215256

WEGOVY

Sponsor: NOVO

APPLICATION
NDA215256
TYPE
NDA
ORIGINAL APPROVAL
2021-06-04
LATEST ACTION
2026-06-18
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

WEGOVY · ReferencePrescription
SEMAGLUTIDE 1MG/0.5ML (1MG/0.5ML) · SOLUTION · SUBCUTANEOUS
WEGOVY · ReferencePrescription
SEMAGLUTIDE 0.25MG/0.5ML (0.25MG/0.5ML) · SOLUTION · SUBCUTANEOUS
WEGOVY · ReferencePrescription
SEMAGLUTIDE 2.4MG/0.75ML (2.4MG/0.75ML) · SOLUTION · SUBCUTANEOUS
WEGOVY · ReferencePrescription
SEMAGLUTIDE 2.4MG/0.75ML (2.4MG/0.75ML) · SOLUTION · SUBCUTANEOUS
WEGOVY · ReferencePrescription
SEMAGLUTIDE 1MG/0.5ML (1MG/0.5ML) · SOLUTION · SUBCUTANEOUS
WEGOVY · ReferencePrescription
SEMAGLUTIDE 0.25MG/0.5ML (0.25MG/0.5ML) · SOLUTION · SUBCUTANEOUS
WEGOVY · ReferencePrescription
SEMAGLUTIDE 0.5MG/0.5ML (0.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
WEGOVY HD · ReferencePrescription
SEMAGLUTIDE 7.2MG/0.75ML (7.2MG/0.75ML) · SOLUTION · SUBCUTANEOUS
WEGOVY FLEXTOUCH · ReferencePrescription
SEMAGLUTIDE 9.6MG/3ML (3.2MG/ML) · SOLUTION · SUBCUTANEOUS
WEGOVY · ReferencePrescription
SEMAGLUTIDE 1.7MG/0.75ML (1.7MG/0.75ML) · SOLUTION · SUBCUTANEOUS
WEGOVY · ReferencePrescription
SEMAGLUTIDE 1.7MG/0.75ML (1.7MG/0.75ML) · SOLUTION · SUBCUTANEOUS
WEGOVY · ReferencePrescription
SEMAGLUTIDE 0.5MG/0.5ML (0.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-06-18Manufacturing (CMC) · Supplement 25 — Label ↗AP
2026-05-05Manufacturing (CMC) · Supplement 31 — Label ↗AP
2026-03-19Efficacy · Supplement 29 · standard — Letter ↗AP
2026-02-25Labeling · Supplement 33 · standard — Letter ↗AP
2026-01-29Labeling · Supplement 30 · standard — Letter ↗AP
2025-11-21Efficacy · Supplement 23 · standard — Letter ↗AP
2025-10-14Labeling · Supplement 26 · standard — Letter ↗AP
2025-08-15Efficacy · Supplement 24 · priority — Label ↗AP
2024-11-27Efficacy · Supplement 15 · standard — Letter ↗AP
2024-11-01Labeling · Supplement 21 · 901 required — Letter ↗AP
2024-03-08Efficacy · Supplement 11 · priority — Label ↗AP
2023-07-21Efficacy · Supplement 7 · standard — Letter ↗AP
2023-02-14Labeling · Supplement 6 · standard — Label ↗AP
2022-12-23Efficacy · Supplement 5 · priority — Label ↗AP
2022-08-24Labeling · Supplement 3 · standard — Label ↗AP
2021-06-04Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · priority — 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →