The Food and Drug Administration announced Friday it had officially declared an end to the nationwide shortage of Ozempic and Wegovy, medications used for diabetes and weight loss.
The agency first declared a shortage of semaglutide, the main ingredient used to make Ozempic and Wegovy, in 2022.
The FDA’s announcement comes months after drugmaker Novo Nordisk told the agency that all dosages of its semaglutide product had become fully available nationwide. The company said in a statement that it confirms the supply of the medications, which are prescription-only, “now meets or exceeds both current and projected U.S. demand.”
“This update comes after ongoing dialogue with the FDA, and substantial efforts by Novo Nordisk to increase manufacturing capacity, including $6.5 billion dollars of investments in the U.S. this year alone,” the drugmaker said.
The FDA said that it will allow compounding pharmacies to continue to make copies of semaglutide for now, which they are usually allowed to do only while the drug is in shortage.
That leeway will continue until April 22 for many pharmacies and May 22 for outsourcing facilities to “avoid unnecessary disruption” to patients, the agency said.
This is similar to what the FDA has granted compounding pharmacies making copies of Eli Lilly’s diabetes and weight loss drug tirzepatide, amid an ongoing lawsuit brought by outsourcing facilities disputing the FDA’s decision to declare the shortage of that weight loss drug over.
Some compounding pharmacies and outsourcing facilities have made millions making copies of semaglutide and tirzepatide during their shortages in recent years, amid a flurry of companies cashing in on demand for the drugs.
The FDA is also facing calls to do more to crack down on counterfeits of the drugs, including from state attorneys general who urged the agency this week to stop illegal imports from overseas.
“Demand for the medications Mounjaro, Zepbound, Ozempic, and Wegovy (GLP-1 drugs) has skyrocketed, but supply shortages and high costs have created opportunities for wrongdoers to cash in and endanger consumers,” they wrote.
