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Wegovy

Wegovy is a brand of semaglutide from Novo Nordisk, first approved by the FDA on 2021-06-04 under applications NDA215256, NDA218316, authorised in the EU as Wegovy, with no open FDA supply records.

Wegovy is Novo Nordisk's brand of semaglutide, covering 2 FDA applications. The same molecule is also sold as Ozempic, Rybelsus — a separate application with its own approved uses and its own supply record, which is why the two are tracked apart here rather than merged. Its current FDA label, effective 2024-04-23, covers cardiovascular disease, obesity. Nothing under this name is currently on the FDA shortage list. It is also authorised in the EU, which does not always follow the US indication wording.

Wegovy and Ozempic, Rybelsus are the same molecule. They are marketed under separate FDA applications with different approved indications, so they are distinct products on the regulatory record even though the active ingredient is identical. Compare the applications below. Side by side: Wegovy vs Ozempic · Wegovy vs Rybelsus.

Active ingredient

semaglutide

Sponsor

Novo Nordisk

FDA applications

NDA215256, NDA218316

First FDA action

2021-06-04

Most recent FDA action

2026-06-18

FDA actions on file

54

EU authorisation

Wegovy

Active trials of semaglutide

203

Approved indications

Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.

FDA record

Every approved submission filed under this brand, newest first, from Drugs@FDA: original approval, efficacy supplements, labeling changes and manufacturing updates. New safety language usually arrives in a labeling supplement.

For the molecule behind this brand — every trial, every indication under study and the full research record — see semaglutide.