NOVO — Ozempic FDA Review (NDA/BLA 209637, 2026)
NOVO · 2026 · FDA Review (Drugs@FDA)
Report summary
The FDA approved Novo Nordisk's Ozempic (semaglutide) on October 14, 2025, for type 2 diabetes, with revisions to its prescribing information. Clinical trials demonstrated Ozempic's efficacy in reducing HbA1c, body weight, major adverse cardiovascular events (MACE), and kidney disease progression, both as monotherapy and in combination. Its safety profile highlights gastrointestinal adverse reactions and hypoglycemia, alongside warnings for acute pancreatitis, thyroid C-cell tumors, and diabetic retinopathy complications. Semaglutide exhibits a long half-life, reducing fasting and postprandial glucose. Regulatory communications detail labeling changes, including adding "headache" and "intestinal obstruction" to postmarketing experience for Ozempic and other GLP-1 receptor agonists, ensuring consistent and accurate information for patients and healthcare providers.
Key findings — cited to the page
| Recent Major Changes - Dosage and Administration | 1/2025 | · p.10 |
| Indication | as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | OZEMPIC · p.1 |
| Approval Date | October 14, 2025 | OZEMPIC · p.1 |
| Initial U.S. Approval | 2017 | OZEMPIC · United States · p.10 |
| sNDA S-035 revision | Revise Warnings and Precautions Section 5.2 Acute Pancreatitis and related language in Section 17 for consistency with the class. | Ozempic · p.4 |
| sNDA S-035 revision | Revise Warnings and Precautions Section 5.7 Severe Gastrointestinal Adverse Reactions to include the statement “Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.” | Ozempic · p.4 |
| sNDA S-037 revision | Add ‘headache’ in Section 6.2, Postmarketing Experience. | Ozempic · p.4 |
| Indication | to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. | OZEMPIC · p.1 |
| sNDA S-035 revision | Add ‘intestinal obstruction, severe constipation including fecal impaction’ and ‘acute kidney injury’ in Section 6.2, Postmarketing Experience. | Ozempic · p.4 |
| Indication | to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. | OZEMPIC · p.1 |
| Recent Major Changes - Indication and Usage | 1/2025 | · p.10 |
| Recent Major Changes - Warnings and Precautions, Severe Gastrointestinal Adverse Reactions | 10/2025 | · p.10 |
Source: NOVO ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →