FDA approves Mounjaro single-dose vials that are never marketed
The FDA approved single-dose vial versions of Mounjaro in July 2023, but Eli Lilly never sold them, and regulators later confirmed the vials were never part of the drug's shortage problem.[1][2]
On July 28, 2023, the Food and Drug Administration approved two supplements to Eli Lilly's Mounjaro (tirzepatide) application that added a single-use glass vial version of the diabetes drug. The approval, signed by Patrick Archdeacon of the FDA's Division of Diabetes, Lipid Disorders, and Obesity, covered a new vial presentation, a manufacturing site to produce it, quality control testing sites, and a secondary packaging site [1]. A second, related supplement updated the drug's label to add warnings about anaphylaxis and angioedema [1].
The vials were approved in the same six strengths already sold in Mounjaro's pre-filled pens: 2.5, 5, 7.5, 10, 12.5, and 15 mg per 0.5 mL [2]. Despite the approval, Lilly did not bring the vials to market in the United States, according to a later FDA order [2]. That distinction matters because Mounjaro pens had been added to the FDA's drug shortage list back in December 2022, due to high demand, and remained there for nearly two years [2]. The vials approved in July 2023, by contrast, were never listed as in shortage, because they were never sold [2].
The FDA revisited this history in a December 19, 2024 order that formally resolved the tirzepatide shortage for both Mounjaro and Zepbound (tirzepatide for weight management) [2]. That order came after the agency's earlier October 2, 2024 decision to declare the shortage over was challenged in federal court by a compounding pharmacy trade group and remanded back to FDA for another look [2]. In its reissued order, FDA said Lilly's supply data showed the company was meeting or exceeding demand for both products, with finished inventory, semi-finished product, and scheduled production sufficient to keep up with projected need [2].
The same order noted that Zepbound, approved as a vial product in March 2024, has followed a similar pattern: only the 2.5 mg and 5 mg vial strengths are currently marketed, and none of the Zepbound vials have ever appeared on the shortage list [2].
Why it matters for patients
For people currently taking or considering Mounjaro, the vial approval itself does not change what is available at the pharmacy, because Lilly has not sold these particular vials in the U.S. [2]. The pens remain the marketed form of Mounjaro. The FDA's clarification is mostly relevant to understanding shortage records: a product can be FDA-approved without ever reaching the market, and its absence from a shortage list does not mean supply issues did not exist elsewhere in the product line [2].
The December 2024 order also addressed compounded versions of tirzepatide, which some patients turned to during the shortage. FDA said it would not pursue enforcement against state-licensed pharmacies compounding under one legal pathway until February 18, 2025, and against outsourcing facilities compounding under another pathway until March 19, 2025 [2]. After those dates, patients relying on compounded tirzepatide may need to check with their pharmacy or prescriber about availability, since the shortage-based justification for that compounding has ended according to FDA [2].
What happens next
FDA said it will continue monitoring supply and demand for tirzepatide products and could add them back to the shortage list if conditions change [2]. The agency also acknowledged that even with the shortage declared resolved nationally, some patients and pharmacies may still see localized, intermittent supply gaps as product moves through wholesalers and distributors [2]. Whether Lilly ever markets the approved Mounjaro vials in the U.S. is not addressed in the available FDA records.
Sources
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