FDA Announces End to Shortage of Semaglutide Products (Ozempic, Wegovy)

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has declared the shortage of semaglutide injection (Ozempic) and semaglutide injection 2.4 mg (Wegovy) is over, resolving the notable supply issues for the management of type 2 diabetes (T2D) and obesity or overweight.¹

Announced by Novo Nordisk, on February 21, 2025, the regulatory agency’s assessment determined the available US supply for the glucagon-like peptide-1 receptor agonist (GLP-RA) medications meets or exceeds the current and expected demand.

“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand,” said Dave Moore, executive vice president of US Operations and Global Business Development and President of Novo Nordisk Inc., in a statement.¹ “No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients.”

Novo Nordisk declared production for semaglutide is underway on an hourly basis, with all doses of semaglutide and semaglutide 2.4 mg shipped regularly to wholesalers. An ongoing dialogue with the FDA and efforts to increase manufacturing capability backed this update, with Novo reporting $6.5 billion in investments in the US to meet demand.

In a statement from the FDA, regulators confirmed with Novo Nordisk that the product availability and manufacturing capability can meet projected national demand, but indicated patients and prescribers may still experience supply disruptions as the product moves across the supply chain.²

Semaglutide’s shortage began in March 2022, according to the FDA’s Drug Shortages list. This update comes on the heels of an increase in interest surrounding compounded semaglutide drug products as the drug was on the shortage list and could be compounded.³ The FDA defines compounding as the “process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.”

To “avoid unnecessary disruption to patient treatment,” the FDA announced no effort to take action against compounders for violations of, emerging from “conditions that depend on semaglutide injection products’ inclusion on FDA’s drug shortage list.”

A state-licensed pharmacy or physician compounding, distributing, or dispensing semaglutide injection products copying an FDA-approved product, under section 503A of the FD&C Act, will have within 60 calendar days from today’s announcement, until April 22, 2025.

"I'm happy to hear that the shortage of semaglutide has been resolved. My hope is this leads to more access for patients that need and benefit from this drug," said HCPLive advisory board member Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic. "I am very concerned about the increase in compounding and lack of oversight of these alternative formulations which can cause patient harm. I hope the GLP-1 manufacturers can continue to meet the demand and work with payers to make these affordable to the people that need them."

For outsourcing facilities compounding, distributing, or dispensing semaglutide injection products copying an FDA-approved drug product, under section 503B of the FD&C Act, will have within 90 calendar days from today’s announcement, until May 22, 2025.

However, the FDA indicated it may still take action against violations of other statutory or regulatory requirements, including products that may be deemed of substandard quality or unsafe.²

Initially approved in 2017 to improve blood sugar in adults with T2D, semaglutide was granted a further indication in 2020 to reduce the risk of major cardiovascular events (MACE) in adults with T2D and known cardiovascular disease (CVD).⁴ In January 2025, semaglutide was awarded additional approval to reduce the risk of kidney failure in adults with T2D and chronic kidney disease (CKD).⁵

The agency gave semaglutide 2.4 mg the green light in June 2021 for chronic weight management in adults with obesity or overweight and ≥1 weight-related condition. The drug received an expanded label indication in March 2024 to include cardiovascular risk reduction in the same population.⁶

References

1. Novo Nordisk. FDA declares Wegovy® and Ozempic® shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses. PR Newswire: press release distribution, targeting, monitoring and marketing. February 21, 2025. Accessed February 21, 2025. https://www.prnewswire.com/news-releases/fda-declares-wegovy-and-ozempic-shortage-is-over-and-that-novo-nordisk-is-fully-meeting-or-exceeding-nationwide-demand-for-all-doses-302382370.html.

2. Center for Drug Evaluation and Research. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. U.S. Food and Drug Administration. February 21, 2025. Accessed February 21, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize.

3. Campbell P. Semaglutide Shortage Prompts FDA Warning to Patients, Providers. June 7, 2023. Accessed February 21, 2025. https://www.hcplive.com/view/semaglutide-shortage-prompts-fda-warning-to-patients-providers

4. Campbell P. Semaglutide (Wegovy) Receives FDA Label Expansion to Include Cardiovascular Risk Reduction. HCPLive. March 8, 2024. Accessed February 21, 2025. https://www.hcplive.com/view/semaglutide-wegovy-receives-fda-label-expansion-to-include-cardiovascular-risk-reduction

5. Kunzmann K. FDA approves semaglutide for Obesity Weight Management. HCPLive. January 17, 2023. Accessed February 21, 2025. https://www.hcplive.com/view/fda-approves-semaglutide-obesity-weight-management.

6. Brooks A. FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease. HCPLive. January 28, 2025. Accessed February 21, 2025. https://www.hcplive.com/view/fda-approves-semaglutide-ozempic-type-2-diabetes-chronic-kidney-disease