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The FDA says all doses of Novo’s Ozempic, Wegovy are now available
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The FDA says all doses of Novo’s Ozempic, Wegovy are now available

All doses of Novo NordiskIts semaglutide — sold as Ozempic for type 2 diabetes and as Wegovy for obesity — are now available, according to a filing on Wednesday update to the FDA’s drug shortage database.

However, the regulator’s webpage continues to list the status of semaglutide as “currently out of stock”. It’s unclear whether compounders will have to stop making and marketing their remixed versions of semaglutide because of Wednesday’s supply update, or if the FDA will take action against those pharmacies.

Earlier this month, the FDA announced that it is rethinking the state of deficit of Eli Lilly’s Mounjaro and Zepbound brands of tirzepatide — which the regulator had removed from the missing list a few days earlier — after a complaint from the Outsourcing Facilities Association (OFA). In its lawsuit, the trade group called the FDA “reckless” in declaring an end to the tirzepatide shortage, saying the decision could “deprive patients of a vital treatment for type 2 and obesity.”

Currently, the FDA officially considers tirzepatide deficiency to be “solved,” according to its website. It remains to be seen whether the OFA will file a similar complaint for semaglutide.

Wednesday’s supply update comes after nearly a year of aggressive manufacturing investment from Novo. In November 2023, the pharmacy announced a $6 billion boost its manufacturing capacity in Denmark, dedicated to a multi-product facility focused on active pharmaceutical ingredients. Novo and in March 2024 injected 556 million dollars in its Chinese operation, following it in June 2024 with a $4.1 billion commitment at its North Carolina manufacturing footprint.

Novo Holdings, the controlling shareholder of Novo Nordisk, announced in February 2024 its $16.5 billion acquisition of the giant CDMO Catalent. In an $11 billion deal, Novo Holdings plans to sell three of Catalent’s sites to Novo Nordisk to help expand production of GLP-1 drugs.

However, the Novo Holdings-Catalent buyout is facing opposition. Earlier this month, Sen. Elizabeth Warren (D-Mass.) incentive Federal Trade Commission Chairman Lina Khan to “closely scrutinize” the Catalent deal, which, if allowed to proceed, will give Novo “unprecedented visibility and control over the manufacturing capacity, costs and business practices of its competitors”.

Lilly CEO David Ricks said in a The Q2 earnings call in August, the company remains preoccupied with the Novo-Catalent business. “We have aired these concerns publicly and privately since the proposed transaction was announced and we are waiting to see what happens,” Ricks told analysts.

Last week, Roche CEO Thomas Schinecker urged regulators to block Novo Holdings’ purchase of Catalent, arguing the deal would have wide-ranging negative effects on the industry.

“Limiting competition in this space is not a good idea,” Schinecker said in a media call. However, he insisted Roche would not be affected by the deal but “could be a problem for other smaller players”, according to Reuters.

Trade unions, consumer groups and public interest organizations also have raised concerns about the acquisition, noting in a letter to Khan that the merger “would be harmful to competition in various therapeutic areas.”