FDA removes tirzepatide from drug shortage list
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Key takeaways:
- The FDA announced on Oct. 2 that Eli Lilly has confirmed the drug shortage of tirzepatide has been resolved.
- The announcement could lead to enforced restrictions on compounded forms of the drug.
Shortages of tirzepatide, a GIP/GLP-1 dual agonist approved for the treatment of type 2 diabetes and obesity, have been resolved, the FDA announced.
On Dec. 15, 2022, the FDA placed tirzepatide (Mounjaro/Zepbound, Eli Lilly) on its drug shortage list due to increased demand for the drug. The announcement came less than 1 year after the medication was first approved for the treatment of type 2 diabetes in May 2022. The drug was later approved for obesity treatment in November 2023.
On Oct. 2, the FDA removed tirzepatide from its drug shortage list after Eli Lilly confirmed the drug’s availability plus manufacturing capacity can meet present and future demand, according to the agency’s announcement. Localized supply disruptions might still occur as the drug moves through the supply chain.
As part of the FDA’s announcement, the agency reiterated legal restrictions on compounded drugs. According to the FDA, section 503A of the Food, Drug & Cosmetic Act contains restrictions on compounded drugs that are “essentially copies of a commercially available drug.” The FDA considers tirzepatide to be commercially available again as it is no longer on the drug shortage list. Additionally, section 503B of the act restricts outsourcing facilities from manufacturing compounded drugs that are copies of one or more FDA-approved drugs.
Eli Lilly and the FDA cautioned the public about counterfeit and compounded tirzepatide earlier in the year. As Healio previously reported, Eli Lilly released a letter on Jan. 4 stating it was taking legal action against some medical spas, wellness centers and compounding pharmacies who were making or selling products claiming to contain tirzepatide. In February, the FDA sent warning letters to US Chem Labs and Synthetix Inc. for introducing unapproved and misbranded forms of tirzepatide and semaglutide (Ozempic/Wegovy, Novo Nordisk) in the marketplace.
Several GLP-1 receptor agonist medications remain on the FDA’s drug shortage list. Medications still in short supply include dulaglutide (Trulicity, Eli Lilly), semaglutide and liraglutide (Saxenda, Novo Nordisk). According to the FDA’s announcement, all but one dose of subcutaneous semaglutide is currently available, while liraglutide has two forms currently available and three doses with limited availability.
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