Ozempic and Wegovy officially moved off FDA's drug shortage list
Ozempic and Wegovy, the widely popular forms of semaglutide sold to treat diabetes and obesity, have officially been removed from the Food and Drug Administration's (FDA) drug shortage list nearly four months after the agency found the drugs to be available.
The FDA's drug shortage list now states that as of Feb. 21, 2025, the shortages of Ozempic and Wegovy injections are over. The shortages were first declared in August 2022.
At the end of October 2024, the FDA had determined there was an available supply of both drugs and that they were no longer "currently in shortage." This occurred shortly after the shortages of Mounjaro and Zepbound had been declared over, setting off concerted pushback from compounding pharmacy groups that were able to sell copycat versions of the drugs while they were in shortage.
Novo Nordisk, the manufacturer of semaglutide, confirmed in a statement Friday that the current supply of its product "meets or exceeds both current and projected U.S. 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, Novo Nordisk executive vice president of U.S. operations and global business development.
"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," he added.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement, "Look, compounding pharmacists have long known that this shortage had a shelf-life." While Brunner questioned whether the shortage was truly over, he said the FDA had done some things "right."
"What FDA did right this time, something it did not do with its abrupt October 2, 2024, resolution of the tirzepatide injection shortage: The agency is providing an off-ramp, a period of time when their pharmacist and provider can transition patients to the FDA-approved drug if it’s available," Brunner stated. "All we can do now is watch what happens as patients hear this news and their providers and pharmacists work to get them a new prescription for the FDA-approved drug."
Under federal law, compounding pharmacies are categorized into 503As and 503Bs. 503As alter medications for patients who may not be able to take them as they're sold, such as liquifying medicines for patients who can't swallow pills. 503Bs are permitted to make large batches of compounded drugs, often for hospitals, and are what telehealth companies have utilized to sell compounded GLP-1s.
One business that invested heavily in compounded GLP-1 medications like semaglutide is the telehealth company Hims & Hers Health. The online company advertised its sale of compounded GLP-1 drugs in a 60-second Super Bowl ad earlier this month, drawing some scrutiny and criticisms.
The company bought its own compounding pharmacy last year. Hims & Hers CEO Andrew Dudum indicated on social platform X that his company would continue to provide compounded semaglutide to the extent it is able.
"We do compound semaglutide. Now that the FDA has determined the drug shortage for semaglutide has been resolved, we will continue to offer access to personalized treatments as allowed by law to meet patient needs," Dudum wrote. "We’re also closely monitoring potential future shortages, as Novo Nordisk stated two weeks ago that it would continue to have 'capacity limitations' and 'expected continued periodic supply constraints and related drug shortage notifications.'"
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Shortage of Novo Nordisk's Wegovy and Ozempic drugs is resolved, FDA says
The FDA's decision will threaten the ability of compounding pharmacies to make far cheaper, unbranded versions of the injections over the next few months.CNBC - 13h -
FDA declares end to Wegovy and Ozempic shortage
The agency first declared a shortage of semaglutide, the main ingredient used to make Ozempic and Wegovy, in 2022.CBS News - 18h -
FDA says Ozempic and Wegovy shortage is ending. That’s bad news for this wellness stock.
“We will continue to offer access to personalized treatments as allowed by law to meet patient needs,” Hims & Hers CEO said.MarketWatch - 16h -
The Ozempic Shortage Is Over—for Now
The resolution could potentially restrict how telehealth programs offer cheaper versions known as compounded drugs.Inc. - 18h -
The Ozempic Shortage Is Over
The semaglutide shortage has officially ended in the US—which means the GLP-1 drug industry is about to undergo massive changes.Wired - 18h -
Top FDA official resigns, warns firings will backfire on RFK Jr.
James Jones resigned as FDA deputy commissioner and said the Trump administration's "indiscriminate" job cuts show "disdain for the very people necessary to implement your agenda."CBS News - 1d -
Shares of Hims & Hers tumble 26% after FDA says semaglutide is no longer in shortage
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Ozempic: $1,400/Month—Compounded Version: $250/Month
The real cost? Your medical license.Inc. - 2d
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