Wegovy, Wegovy Hd, Wegovy Flextouch

Lowers the risk of major adverse cardiovascular events (cardiovascular death, non-fatal…. NDA 215256, held by Novo. Semaglutide.

As of Nov 14, 2026, NDA 215256 (Wegovy, Wegovy Hd, Wegovy Flextouch), held by Novo, was first approved by FDA on Jun 4, 2021, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 4, 2021
Review: Priority
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

WEGOVY is indicated in combination with a reduced calorie diet and increased physical activity:

to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.
to reduce excess body weight and maintain weight reduction long term in: o Adults and pediatric patients aged 12 years and older with obesity o Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use
WEGOVY contains semaglutide.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Mar 19, 2026	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Nov 21, 2025	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 15, 2025	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 27, 2024	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 8, 2024	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Jul 21, 2023	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 23, 2022	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 4, 2021	Original applicationNew indication · Priority review	Approved	Review Label Letter

Products

12 strengths and forms


Wegovy0.25MG/0.5ML (0.25MG/0.5ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy0.5MG/0.5ML (0.5MG/0.5ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy1MG/0.5ML (1MG/0.5ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy1.7MG/0.75ML (1.7MG/0.75ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy2.4MG/0.75ML (2.4MG/0.75ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy Hd7.2MG/0.75ML (7.2MG/0.75ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy0.25MG/0.5ML (0.25MG/0.5ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy0.5MG/0.5ML (0.5MG/0.5ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy1MG/0.5ML (1MG/0.5ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy1.7MG/0.75ML (1.7MG/0.75ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy2.4MG/0.75ML (2.4MG/0.75ML) · solution;subcutaneous	Semaglutide	RxReference drug
Wegovy Flextouch9.6MG/3ML (3.2MG/ML) · solution;subcutaneous	Semaglutide	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 25Manufacturing	Approved	Label
May 5, 2026	Supplement 31Manufacturing	Approved	Label Letter Review
Mar 19, 2026	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Feb 25, 2026	Supplement 33Labeling · Standard review	Approved	Label Letter
Jan 29, 2026	Supplement 30Labeling · Standard review	Approved	Letter Label
Nov 21, 2025	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 14, 2025	Supplement 26Labeling · Standard review	Approved	Letter Label
Aug 15, 2025	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 27, 2024	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 1, 2024	Supplement 21Labeling	Approved	Letter Label
Mar 8, 2024	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Jul 21, 2023	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 14, 2023	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 23, 2022	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 24, 2022	Supplement 3Labeling · Standard review	Approved	Label
Jun 4, 2021	Original applicationNew indication · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 215256
Drugs@FDA: Overview at FDA
Company: Novo

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters