The Ozempic shortage is over, says FDA

The semaglutide crisis is reportedly over in the United States. Will Australia’s stock soon be replenished?

Ozempic has been on the market since 2017. But a 2021 clinical trial, linking Ozempic to significant weight loss, led to an explosion in off-label use of the drug.

As such, Ozempic has been in short supply worldwide since 2022, with demand, fuelled by off-label use for weight loss, massively outstripping supply. The injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) has been on the Therapeutic Goods Administration’s (TGA’s) medicine shortage database since April 2022.

But the United States Food and Drug Administration (FDA), has officially declared that the Ozempic and Wegovy shortage is  over, with supply now meeting demand. Similar to Australia, the FDA declared that selling or making compounded versions of these drugs is now rendered illegal, with rare exceptions – since the drug is no longer considered to be in short supply.

All doses of these GLP-1RA medicines are being continuously shipped, supported by 24/7 production and significant investments in manufacturing, said Novo Nordisk.

‘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, US. Operations and Global Business Development and President of Novo Nordisk Inc.

‘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.’

According to some, the move is premature. The FDA has been hit with lawsuits by a trade associate and compounders for what they claim is an improper reliance on  the manufacturers’ assurances that they could meet demand, without taking into account evidence showing that patients were still struggling to access the medicines.

Could Australia follow suit?

Not yet. 

Novo Nordisk has informed the TGA that supply of Ozempic will continue to be limited until 31 December 2025, a spokesperson for Novo Nordisk told Australian Pharmacist.

‘This is due to the continued, unprecedented demand for Ozempic in Australia and around the world,’ said the spokesperson.

Novo Nordisk said it has continued to make significant investments to expand its global manufacturing capacity and meet demand to the greatest extent possible.

‘Since 2023, Novo Nordisk has committed to investing at least 41 billion AUD to build production capacity,’ said the spokesperson. ‘However, it takes time to build supply levels to meet global and local demand.’

It’s important to continue to follow the joint guidance issued by the TGA and various professional bodies on this matter, said the spokesperson.

‘Novo Nordisk will continue to work with the TGA to provide updates on this matter.’

What does the TGA advise?

Pharmacists are advised to inform patients that supply of Ozempic is expected to be limited in 2025 and discuss alternative treatments when patients are unable to access the medicine.

The TGA has said that both Ozempic and Wegovy should be prescribed and supplied according to their approved indications; for the management of type 2 diabetes and chronic weight management respectively.

‘Pharmacists should be aware that stock availability can change and sudden spikes in demand due to stockpiling or off-label use may affect continuity of care for patients stabilised on Ozempic,’ said the TGA.

Will GLP-1 RAs be subsidised for weight loss?

While Ozempic is subsidised on the Pharmaceutical Benefits Scheme (PBS) for type 2 diabetes, there is no GLP-1 RA that is TGA indicated for weight loss that is currently subsidised under the PBS. 

As a result, Australians using Wegovy for weight loss must pay approximately $250–500 out of pocket each month.

However, since early 2025, in the United Kingdom, people who meet certain BMI criteria and have at least one weight-related co-morbidity have been able to access semaglutide (Wegovy) and tirzepatide (Mounjaro) for weight management.

In November 2023, PBAC reviewed Novo Nordisk’s request to list semaglutide on the PBS for adults with severe obesity and at least two weight-related conditions, including obstructive sleep apnoea, osteoarthritis of the knee, or pre-diabetes. PBAC rejected the proposal, citing concerns it didn’t consider the drug cost-effective at the price proposed. 

While recognising the long-term benefits of weight loss for people at risk of developing heart disease, diabetes or stroke, these were not factored into its cost-effectiveness assessment. PBAC suggested a future submission focus on patients with heart disease, type 2 diabetes, or multiple high-risk factors such as high blood pressure, cholesterol, or kidney disease.

Novo Nordisk previously told AP that it plans to resubmit an application to PBAC for Wegovy, factoring in these conditions since the drug’s new TGA indication for cardiovascular disease.

‘Novo Nordisk plans to resubmit Wegovy to the PBAC in 2025,’ said the spokesperson.