Novo Nordisk's Ozempic and Wegovy now available in the U.S. after shortages, FDA says

All doses of Novo Nordisk‘s highly popular weight loss injection Wegovy and diabetes drug Ozempic are now available in the U.S., according to an update on the U.S. Food and Drug Administration’s drug shortage database Wednesday. 

It is a sign that Novo Nordisk’s efforts to ramp up the supply of those weekly drugs are starting to pay off, as demand continues to skyrocket in the U.S.  

A previous update said the lowest dose of Wegovy — 25 milligrams — was still in short supply.

Several doses of semaglutide, the active ingredient in Wegovy and Ozempic, have been on the FDA’s shortage list since early 2022. 

Wednesday’s update raises the potential that the FDA might remove the blockbuster injections from its shortage list entirely, which could prevent compounding pharmacies from making customized and often cheaper versions of those branded drugs.

In a statement, Novo Nordisk said all doses of Wegovy and Ozempic are being shipped regularly to wholesalers. The Danish drugmaker said the FDA’s update is a result of the company’s significant investment in expanding manufacturing capacity and “ongoing communication” with the agency. 

Still, Novo Nordisk said patients may not always be able to immediately fill their prescriptions at a particular pharmacy, even when a medication is listed as available. 

“Our intentional approach to gradually increase supply into the U.S. market is working,” Novo Nordisk said. “We will continue to prioritize continuity of care for patients, closely monitoring market dynamics and prescribing trends along the way.”

It comes a week after Novo Nordisk asked the FDA to prevent compounding pharmacies from making unapproved versions of Wegovy and Ozempic, arguing that the medications are too complex for those manufacturers to make safely. 

Earlier this month, the FDA removed tirzepatide, the active ingredient in Eli Lilly‘s weight loss drug Zepbound and diabetes treatment Mounjaro, from its shortage list. But a trade group representing some compounders sued the FDA, which led the agency to say it will reconsider its decision to remove tirzepatide from its shortage list.