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FDA NDA · NDA206321

SAXENDA

liraglutide

Sponsor: NOVO

APPLICATION
NDA206321
TYPE
NDA
ORIGINAL APPROVAL
2014-12-23
LATEST ACTION
2026-06-02
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SAXENDA · ReferencePrescription
LIRAGLUTIDE 18MG/3ML (6MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-06-02Labeling · Supplement 24 · standard — Letter ↗AP
2026-02-25Labeling · Supplement 25 · standard — Letter ↗AP
2025-10-14Labeling · Supplement 22 · standard — Letter ↗AP
2025-05-28Labeling · Supplement 20 · standard — Letter ↗AP
2024-11-01Labeling · Supplement 19 · 901 required — Label ↗AP
2023-04-20Labeling · Supplement 16 · standard — Letter ↗AP
2022-06-15Labeling · Supplement 15 · standard — Letter ↗AP
2020-12-04Labeling · Supplement 14 · standard — Letter ↗AP
2020-12-04Efficacy · Supplement 12 · standard — Letter ↗AP
2020-12-04Labeling · Supplement 13 · standard — Letter ↗AP
2020-03-25Efficacy · Supplement 11 · standard — Label ↗AP
2018-12-04REMS · Supplement 9 — Letter ↗AP
2018-10-19Efficacy · Supplement 7 · standard — Label ↗AP
2017-05-22REMS · Supplement 5 — Letter ↗AP
2017-04-26Labeling · Supplement 6 · standard — Label ↗AP
2017-04-26Efficacy · Supplement 4 · standard — Label ↗AP
2016-09-22Labeling · Supplement 3 · standard — Label ↗AP
2016-02-01REMS · Supplement 2 — Letter ↗AP
2015-03-27Labeling · Supplement 1 · standard — Label ↗AP
2014-12-23Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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