Packages containing syringes of the drugs Wegovy, Ozempic and Mounjaro at a store in Mitte, Germany, July 11, 2024.
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All doses of Novo Nordisk‘s extremely fashionable weight reduction injection Wegovy and diabetes drug Ozempic at the moment are out there within the U.S., in keeping with an update on the U.S. Meals and Drug Administration’s drug scarcity database Wednesday.
It’s a signal that Novo Nordisk’s efforts to ramp up the supply of these weekly medicine are beginning to repay, as demand continues to skyrocket within the U.S.
A earlier replace mentioned the bottom dose of Wegovy — 25 milligrams — was nonetheless briefly provide.
A number of doses of semaglutide, the energetic ingredient in Wegovy and Ozempic, have been on the FDA’s scarcity checklist since early 2022.
Wednesday’s replace raises the potential that the FDA may take away the blockbuster injections from its scarcity checklist totally, which might stop compounding pharmacies from making personalized and infrequently cheaper variations of these branded medicine.
In a press release, Novo Nordisk mentioned all doses of Wegovy and Ozempic are being shipped commonly to wholesalers. The Danish drugmaker mentioned the FDA’s replace is a results of the corporate’s vital funding in increasing manufacturing capability and “ongoing communication” with the company.
Nonetheless, Novo Nordisk mentioned sufferers might not all the time be capable to instantly fill their prescriptions at a selected pharmacy, even when a drugs is listed as out there.
“Our intentional method to progressively enhance provide into the U.S. market is working,” Novo Nordisk mentioned. “We are going to proceed to prioritize continuity of look after sufferers, carefully monitoring market dynamics and prescribing developments alongside the best way.”
It comes every week after Novo Nordisk requested the FDA to prevent compounding pharmacies from making unapproved variations of Wegovy and Ozempic, arguing that the drugs are too advanced for these producers to make safely.
Earlier this month, the FDA eliminated tirzepatide, the energetic ingredient in Eli Lilly‘s weight loss drug Zepbound and diabetes remedy Mounjaro, from its scarcity checklist. However a commerce group representing some compounders sued the FDA, which led the company to say it can rethink its determination to take away tirzepatide from its scarcity checklist.