FDA approves multiple-dose tirzepatide vials for Mounjaro and Zepbound

The FDA has approved Eli Lilly supplements that add a multiple-dose single-patient-use vial to the labeling for both of its tirzepatide brands, Mounjaro and Zepbound ^[1][2].

The agency approved two Prior Approval supplemental new drug applications: S-041 for Mounjaro (NDA 215866) and S-037 for Zepbound (NDA 217806) ^[1][2]. Both supplements were dated and received July 31, 2025 ^[1][2]. The approval letters were signed January 7, 2026, by John Sharretts, MD, director of the FDA's Division of Diabetes, Lipid Disorders, and Obesity, and the approvals are effective on the date of the letters ^[1][2].

According to the letters, each supplement "provides for revisions to the Prescribing Information and Medication Guide, and new carton and container labeling and Instructions for Use to include an additional presentation, the multiple-dose single-patient use vial" ^[1][2]. The enclosure lists for both letters include an "Instructions for Use- multi-dose vial," alongside the previously approved instructions for the single-dose vial and single-dose pen ^[1][2].

Both products already had vials and pens on the market. The Zepbound letter lists a single-dose vial Instructions for Use previously approved March 28, 2024, and a single-dose pen version approved November 8, 2023 ^[1]. The Mounjaro letter lists a single-dose vial version dated July 28 and a single-dose pen version dated May 13, 2022 ^[2].

The letters do not give the new vial's concentration, the number of doses it contains, a price, or a launch date ^[1][2]. The approved labeling name uses "single-patient-use," which indicates the vial is intended for one patient rather than shared among patients; how many doses a patient draws from it has not been reported ^[1][2]. Neither letter says whether the vial will be priced differently from the pens or single-dose vials, or how doses are measured or given from it ^[1][2]. That detail would appear in the Instructions for Use, which is part of the approved labeling but is not included in the letters ^[1][2].

FDA also said both applications are exempt from the Pediatric Research Equity Act requirement for pediatric assessments, because they do not add a new active ingredient, indication, dosage form, dosing regimen or route of administration ^[1][2]. Both products are described in the letters as Part 3 combination products ^[1][2].

Why it matters for patients

For people using tirzepatide, this adds another delivery format to what is available under the Mounjaro and Zepbound labels, alongside the single-dose vial and single-dose pen ^[1][2]. Mounjaro and Zepbound are separate applications for the same molecule, tirzepatide, and each brand received its own approval letter for the new presentation ^[1][2].

An FDA approval of a labeling supplement is not the same as a product being available in pharmacies. Whether the new vial is stocked, what it costs, and whether insurers cover it are separate questions that the letters do not address ^[1][2]. If price and coverage matter to a patient's decision, those details have not been disclosed in these documents.

Nothing in the letters changes the approved instructions for the existing pen or single-dose vial presentations; the prior Instructions for Use remain listed as enclosures ^[1][2].

What happens next

Lilly must submit the content of labeling in structured product labeling format within 14 days of the letters ^[1][2]. Final printed carton and container labeling must be submitted no more than 30 days after they are printed, and FDA approval is not required before that labeling is used ^[1][2]. The company must also file any required patent information on Form FDA 3542 within 30 days of approval for it to be timely ^[1][2]. No date for when the multiple-dose single-patient-use vial will be available to patients has been announced ^[1][2].