Ozempic and Wegovy Officially Taken Off Shortage List
The popular medications may still suffer from local shortages, but FDA is confident that the national supply will remain stable.
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FDA officially declared that popular GLP-1s Wegovy and Ozempic are no longer in shortage.1
The two drugs soared in popularity in recent years due to their potential to help with weight-loss. The medicines were originally developed as diabetes treatments but have since become more widely known as weight-loss assistance drugs.
Due to the high demand, Novo Nordisk limited new prescriptions starting back in 2022. Those limitations eased in 2024, although demand was still putting pressure on the supply chain. According to a new statement from FDA, it appears that Novo Nordisk is able to meet the demand.
In a statement on its website, the agency wrote, “FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”
The statement continues, “To avoid unnecessary disruption to patient treatment, the agency does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on semaglutide injection products’ inclusion on FDA’s drug shortage list.”
FDA continued that statement by clarifying its regulations on compounding medications under both sections 503A and 503b of the FD&C act.
FDA also provided a statement from Robert Fischer, director of regulatory affairs at Novo Nordisk, which goes into further detail about the current state of the supply chain.2
Fischer writes, “As a result of this review, we conclude that the information and data Novo Nordisk has provided to 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. After carefully evaluating the information from sources other than Novo Nordisk, we find that it has important limitations. We conclude that this information does not undermine or outweigh the evidence demonstrating that Novo Nordisk’s supply is currently meeting or exceeding demand and that, based on our best judgment, it will meet or exceed projected demand.”
Sources
- FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize. FDA. February 21, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- Fischer, Robert. Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy). February 21, 2025. www.fda.gov/media/185526/download?attachment
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