FDA removes most doses of Ozempic from drug shortage list after Novo Nordisk resolves supply issues

USA — Novo Nordisk’s Ozempic, a treatment for type 2 diabetes and off-label for weight loss, is no longer on the FDA’s drug shortage list after months of limited supply.

The FDA updated its website to show that Ozempic’s 0.25 mg, 0.5 mg, and 1 mg doses are available across the US, while the 2 mg dose has “limited availability.”

Novo Nordisk attributed the 2 mg dose shortage to high demand and supply constraints. Ozempic contains the same medicine, semaglutide, as Wegovy, Novo Nordisk’s weight loss drug approved in June 2021.

While the removal from the FDA list suggests improved supply, it does not guarantee stock availability in all regions.

According to Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, drug availability depends on how quickly manufacturers can supply wholesalers and how fast wholesalers can replenish their stocks and fulfill orders.

Therefore, even if the manufacturer has released product, some regions or pharmacies may still experience shortages.

In mid-December, Novo Nordisk confirmed supply disruptions for Ozempic but did not confirm whether the shortages were related to the drug’s off-label use as a weight loss treatment.

The company acknowledged that some providers may be prescribing the drug for such use but emphasized that it does not promote or encourage off-label use.

Novo Nordisk spent roughly US$1.8 billion last year to expand its capacity and is restructuring its supply chains.

Eli Lilly also faced a similar shortage for its GLP-1 drug Mounjaro, but all doses are currently available according to the FDA’s database.

Eli Lilly plans to double its manufacturing capacity for Mounjaro by the end of 2023.

In the U.S., prescriptions for diabetes drugs are on the rise. In December, Eli Lilly announced that its newly approved type 2 diabetes drug, Mounjaro, had surpassed its own established drug Trulicity, with 180,000 prescriptions per week.

Mounjaro has also received a fast track designation from the FDA for the treatment of adults with obesity or who are overweight with weight-related comorbidities.

Meanwhile, Novo Nordisk has urged patients concerned with continuity of treatment to contact their healthcare provider regarding the limited availability of Ozempic’s 2 mg doses.

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