Drug Trial Snapshot: Ozempic | FDA - U.S. Food and Drug Administration
Aug 20, 2020 · The FDA considered the results of five randomized, multinational clinical trials to evaluate the efficacy of OZEMPIC in the treatment of adult patients with type 2 diabetes mellitus.
FDA approves Ozempic to reduce risks from chronic kidney …
Jan 28, 2025 · Ozempic and other semaglutide injections such as Wegovy have been in short supply for years due to their rapid popularity. The FDA now lists Ozempic as “available,” but there is still high demand.
OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1).
OZEMPIC has been studied as monotherapy and in combination with metformin, metformin and sulfonylureas, metformin and/or thiazolidinedione, and basal insulin in patients with type 2 diabetes mellitus. The efficacy of OZEMPIC was compared with placebo, sitagliptin, exenatide extended-release (ER), and insulin glargine.
FDA warns consumers not to use counterfeit Ozempic …
FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product.
FDA approves Ozempic® (semaglutide) as the only GLP-1 RA to …
Jan 28, 2025 · Today, the FDA has expanded the benefits of Ozempic ® to a new patient population that needs critical treatment options to reduce the risk of kidney disease worsening, kidney failure (end-stage...
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
Oct 2, 2024 · FDA is aware of counterfeit Ozempic marketed in the U.S. Counterfeit drugs claim to be authentic, but could contain the wrong ingredients, contain too little, too much or no active ingredient...
Novo Nordisk's Ozempic wins FDA approval for chronic kidney …
Jan 28, 2025 · Expanded Ozempic approval in the U.S. could transform how doctors treat patients with chronic kidney disease, which involves a gradual loss of kidney function.
FDA Approves Ozempic to Protect Kidneys in Patients With Type …
Jan 29, 2025 · The U.S. Food and Drug Administration (FDA) has officially approved Ozempic to help reduce the risk of serious kidney complications in people with type 2 diabetes and chronic kidney disease.
OZEMPIC is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus[see Clinical Studies (14.1)]. to reduce the risk of major adverse...