Ozempic’s Fast-Track to Fame: What the FDA Actually Approved

Publish Date : 06/12/2025

In December 2016, pharmaceutical giant Novo Nordisk asked the FDA to approve a new diabetes treatment: semaglutide, later branded as Ozempic. Just one year later, the FDA gave its stamp of approval, allowing Novo Nordisk to market the once-weekly injectable drug to help manage blood sugar in adults with type 2 diabetes. The company promised the drug had a “safe and well tolerated” profile — downplaying nausea as the only commonly reported issue in trials.

Since then, the FDA has approved multiple expanded uses for Ozempic. In 2020, the agency allowed the company to market Ozempic as a drug capable of reducing major cardiovascular events in patients with type 2 diabetes and heart disease. Then, in 2022, the FDA signed off on a higher-dose version (2 mg), widening the drug’s potential reach and profitability even further.

Behind the scenes, however, serious questions remain — especially about what the FDA approved, what it didn’t, and how the drug has been marketed since. As the demand for weight-loss drugs skyrockets, it’s time to take a hard look at how quickly Ozempic moved through the regulatory pipeline — and whether the full picture of its risks was really brought into focus.

Want to find out if you or a loved one has an Ozempic (GLP-1) claim?

Please feel free to contact an Ozempic Lawsuit attorney at info@westrikeback.com or 1-877-542-4646. One of our experienced Ozempic Lawsuit lawyers will help evaluate your claim and explain your legal rights for free. McSweeney / Langevin is providing consultations to individuals throughout the United States. Information provided by email or phone will be kept confidential.