FDA Says Ozempic, Wegovy Shortage Resolved

The FDA has declared the shortage of semaglutide (Ozempic, Wegovy) has been resolved, confirming that the US supply of the prescription-only medications now meets or exceeds the current and projected demand. Semaglutide has been in shortage since March (Wegovy) and August (Ozempic) 2022 due to increased demand, according to the FDA.^1,2

The FDA said that there may be intermittent and limited localized supply disruptions due to products moving through the supply chain. | Image Credit: Araki Illustrations | stock.adobe

"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. 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," Dave Moore, executive vice president of US operations and global business development and president of Novo Nordisk Inc, said in a statement.¹ "Patient safety remains our top priority, and, in line with our purpose to improve lives and health, we continue to partner, educate, and advocate for expanded, affordable access to our medicines for those who need and rely on them."

In a letter addressed to Novo Nordisk, Jacqueline Corrigan-Curay, JD, MD, acting director for the CDC and FDA, stated, “As a result of this review, we conclude that the information and data Novo Nordisk has provided to the FDA demonstrate that Novo Nordisk’s supply is currently meeting or exceeding demand for its semaglutide injection products and that Novo Nordisk has developed reserves that it now holds in its finished product inventory in addition to significant units of semi-finished product, such that supply will meet or exceed projected demand.”³

The FDA said that there may be intermittent and limited localized supply disruptions due to products moving through the supply chain, but it will not take action against compounders violating the Food, Drug & Cosmetic Act for state-licensed pharmacy or physician compounding under section 503A and for outsourcing facilities under sections 503B until April 22, 2025, and May 22, 2025, respectively. The agency can still take action against any other violations of any other statutory or regulatory requirements, including addressing unsafe or substandard quality products.²

Previously, the FDA noted that semaglutide injections were in shortage on October 2, 2024, but that Novo Nordisk had reported all but on presentation. On December 19, 2024, the FDA updated that after all presentations were reported, the product was still in shortage and the agency would actively monitor the drug availability to determine if the demand and projected demand for each drug exceeded the available supply.³

The FDA also affirmed that dulaglutide injection (Trulicity) and liraglutide (Victoza, Saxenda) injection are still in drug shortage but have presentations available.²

REFERENCES

1. FDA declares Wegovy and Ozempic shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses. News release. Novo Nordisk. February 21, 2025. Accessed February 21, 2025. https://prnmedia.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. FDA. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. Updated 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. FDA. Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy). February 21, 2025. Accessed February 21, 2025. https://www.fda.gov/media/185526/download?attachment

4. FDA. Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound). December 19, 2024. Accessed February 21, 2025. https://www.fda.gov/media/184606/download