FDA confirms end of tirzepatide shortage
Key takeaways:
- After a second investigation, the FDA announced tirzepatide will no longer be on the agency’s drug shortage list.
- Dates were announced for distribution of compounded forms for the drugs to end.
The FDA has confirmed there is no longer a shortage of tirzepatide and has set dates for companies to cease distribution of compounded forms of the agent, according to an announcement from the agency.
As Healio previously reported, the FDA announced Oct. 2 that tirzepatide (Mounjaro/Zepbound, Eli Lilly) had been removed from its drug shortage list after it confirmed with Eli Lilly that availability of the drug and manufacturing capacity could meet national demand. On Oct. 22, the FDA remanded the decision for reevaluation as part of litigation. After a second analysis, the FDA again announced the shortage of tirzepatide had been resolved Dec. 19.
In its announcement, the FDA said it will not take immediate action against compounders for violations of the Federal Food, Drug and Cosmetic Act that are tied to “conditions that depend on tirzepatide injection products’ inclusion on FDA drug shortage list.” The agency said no violations for manufacturing or distributing compounded tirzepatide will be issued against state-licensed pharmacies until after Feb. 18 and for outsourcing facilities until after March 19.
Both Eli Lilly and the FDA have raised concerns about compounded or counterfeit tirzepatide in 2024. In an open letter released in January 2024, Eli Lilly advised patients to avoid compounded forms of tirzepatide, which the company claimed could lead to serious health risks. In February, the FDA sent warning letters to two companies for offering unapproved forms of semaglutide and tirzepatide for sale on their websites.
The agency also reaffirmed on Dec. 19 that other GLP-1 receptor agonists remain on the FDA drug shortage list, including dulaglutide (Trulicity, Eli Lilly), semaglutide (Ozempic/Wegovy, Novo Nordisk) and liraglutide (Saxenda, Novo Nordisk). Both dulaglutide and semaglutide have all presentations of the drug currently available, whereas liraglutide has two presentations available and three with limited availability, according to the FDA.