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

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

Yet the regulator’s web page continues to list semaglutide’s status as “currently in shortage.” It’s unclear whether compounding companies will have to stop producing and marketing their remixed versions of semaglutide because of Wednesday’s supply update — or whether the FDA will force action against these pharmacies.

Earlier this month, the FDA announced that this was the case reconsidering the deficit status of Eli Lilly’s tirzepatide brands Mounjaro and Zepbound, which the regulator had removed from the shortage list just days earlier – following a complaint from the Outsourcing Facilities Association (OFA). In its lawsuit, the trade group called the FDA “reckless” in declaring the end of the tirzepatide shortage, noting that the decision “could deprive patients of an essential treatment for type 2 and obesity.”

Currently, the FDA still officially considers the tirzepatide shortage as “dissolved,” the website said. It remains to be seen whether OFA will file a similar complaint for semaglutide.

Wednesday’s supply update comes after nearly a year of aggressive manufacturing investments from Novo. In November 2023, the pharmaceutical company announced a A $6 billion boost to its production capacity in Denmark, dedicated to a multi-product facility focused on active pharmaceutical ingredients. Novo in March 2024 too $556 million injected in its Chinese operations, followed in June 2024 with a Commitment of $4.1 billion to its manufacturing footprint in North Carolina.

Novo Holdings, the controlling shareholder of Novo Nordisk, made its… $16.5 billion acquisition from CDMO giant Catalent. In a related deal worth $11 billion, Novo Holdings plans to sell three of Catalent’s sites to Novo Nordisk to help expand production of its GLP-1 drugs.

However, the acquisition of Novo Holdings and Catalent is encountering opposition. Earlier this month, Sen. Elizabeth Warren (D-Mass.) said urged Lina Khan, chair of the Federal Trade Commission, will “carefully examine” the Catalent deal, which, if it goes through, will give Novo “unprecedented insight and control over its competitor’s manufacturing capacity, costs and business practices.”

Lilly CEO David Ricks said in a Second quarter earnings figures in August that the company remains concerned about the Novo-Catalent deal. “We have raised 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’ takeover of Catalent, arguing the deal would have far-reaching negative consequences for the sector.

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

Trade unions, consumer groups and public interest groups have done so too concerns expressed about the acquisition, noting in a letter to Khan that the merger “would be detrimental to competition in several therapeutic areas.”