Ozempic, Wegovy Shortage Is Officially Over

Compounders given 60- to 90-day notice

https://www.medpagetoday.com/endocrinology/diabetes/114324

The shortage of semaglutide injections (Ozempic, Wegovy) is over, the FDA announced on Friday.

The agency, along with maker Novo Nordisk, confirmed that supply now meets or exceeds both the current and projected U.S. demand. The injectable formulation of the GLP-1 receptor agonist has been in shortage since August 2022 due to increased demand.

“Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies,” the FDA noted in a statement.

The shortage resolution applies to all strengths of semaglutide for type 2 diabetes, chronic weight management and major adverse cardiovascular event risk reduction.

The FDA said it will give compounders a grace period of 60 to 90 days to finish producing, distributing, and dispensing copies of semaglutide injection products to “avoid unnecessary disruption to patient treatment.”

Compounders are allowed to make copies of a drug only when it’s on the FDA shortage list, meaning the demand or projected demand of that drug exceeds the U.S. supply.

“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 of U.S. operations and global business development and president of Novo Nordisk, in a statement

“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.

Two other GLP-1 receptor agonist products — dulaglutide (Trulicity) and liraglutide (Victoza, Saxenda) — still remain in shortage, the FDA noted.

Filed under: General Problems