FDA approves Wegovy for weight management in obesity

On June 4, 2021, the FDA cleared Wegovy for chronic weight management in adults with obesity, or in adults who are overweight and have at least one related health condition ^[1]. Novo Nordisk makes the drug, and federal records show the decision was handled under application 215256 on a priority timeline ^[1][4].

Wegovy is semaglutide, the same GLP-1 receptor agonist sold as Ozempic for type 2 diabetes ^[1][3]. It is injected once a week beneath the skin of the abdomen, thigh or upper arm, at any hour, with or without food ^[1]. The original label offered pens delivering 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg, and directed that the drug be used alongside a reduced-calorie diet and more physical activity, including to keep lost weight off ^[1]. Anyone already taking semaglutide, or any other GLP-1 medicine, was told not to add it ^[1].

Semaglutide had been on the US market for more than three years by then, but only for diabetes. Ozempic's first approval came on December 5, 2017, and Rybelsus tablets followed on September 20, 2019 ^[3]. Wegovy was the first version of the molecule carrying a weight-loss claim ^[3].

The label carries a boxed warning about thyroid C-cell tumors ^[1]. Other warnings cover pancreatitis, gallbladder disease, low blood sugar, kidney injury, serious allergic reactions, diabetic eye complications, a faster heart rate, suicidal thoughts and behavior, and aspiration during deep sedation or general anesthesia ^[1]. Side effects reported in at least 5% of participants in the studies behind the label include nausea, diarrhea, vomiting, constipation, stomach pain, headache, fatigue, indigestion, dizziness, bloating, burping, low blood sugar in people with type 2 diabetes, gas, gastroenteritis, acid reflux and nasopharyngitis, or cold symptoms ^[1].

One date in the record does not line up. An FDA notice tied to a later liver-disease approval states that Wegovy "was first approved in 2017" ^[2]. The agency's own application file and Drugs.com both give June 4, 2021 as the original Wegovy approval ^[1][4]; 2017 is the year Ozempic reached the market ^[3].

Why it matters for patients

Two brand names now share one molecule. Because Wegovy and Ozempic both contain semaglutide, the Wegovy label advises against using them together or pairing either with another GLP-1 receptor agonist ^[1]. The difference between the products is the approved use and the label, not the active ingredient.

Coverage was narrow at first. The 2021 indication named adults only, and it did not include protection against heart attacks or strokes ^[1]. Teens aged 12 and older with obesity were added on December 23, 2022 ^[1][4].

What happened after

The label has grown through a series of approvals:

• December 23, 2022: obesity treatment extended to patients aged 12 and older ^[1][4].
• March 8, 2024: cleared to reduce the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease plus obesity or overweight ^[1][4].
• August 15, 2025: accelerated approval for noncirrhotic MASH with moderate to advanced liver fibrosis ^[1][2]. In an 800-person phase 3 trial, 63% of those on Wegovy saw MASH resolve with no worsening of scarring at week 72, against 34% on placebo; 37% had less scarring with no worsening MASH, against 22% ^[2].
• December 22, 2025: a once-daily Wegovy tablet, taken on an empty stomach, was approved ^[1][3].
• March 19, 2026: a higher-dose injection, listed at 7.2 mg, was approved ^[1][4].

Whether the liver changes measured at 72 weeks lead to fewer deaths, transplants or liver-related events is still being tested; the trial is scheduled to run 240 weeks ^[2].