Lilly files multi-dose vial supplements for both tirzepatide brands

Eli Lilly has won Food and Drug Administration approval to sell both of its tirzepatide products, Mounjaro and Zepbound, in a new multiple-dose, single-patient-use vial. The company submitted the supplemental applications on July 31, 2025, and the FDA's approval letters were signed on January 7, 2026 ^[1][2].

The changes came through what the FDA calls Prior Approval supplements, filed under Chemistry, Manufacturing, and Controls, or CMC, rules. For Zepbound, the supplement is numbered S-037 under NDA 217806 ^[1]. For Mounjaro, it is S-041 under NDA 215866 ^[2]. Both letters describe the same change: adding "an additional presentation, the multiple-dose single-patient use vial" to each drug's approved forms, alongside the existing single-dose vials and single-dose pens ^[1][2].

Approval covered more than the vial itself. The FDA signed off on revised Prescribing Information, updated Medication Guides, new carton and container labeling, and new Instructions for Use specific to the multi-dose vial for both drugs ^[1][2]. Lilly must now submit finalized labeling content within 14 days of the letters and file final printed carton and container labeling within 30 days after it is printed, though FDA approval of that printed material is not required before it can be used ^[1][2]. The company must also submit any required patent information to the FDA within 30 days of approval, for listing in the Orange Book ^[1][2].

Both letters note that the supplements did not involve a new active ingredient, new indication, new dosing regimen, or new route of administration, so Lilly was exempted from pediatric assessment requirements under the Pediatric Research Equity Act ^[1][2]. The FDA reviewers on both applications were the same: John Sharretts, MD, Director of the Division of Diabetes, Lipid Disorders, and Obesity, signed both approval letters ^[1][2].

Why it matters for patients

A multi-dose, single-patient-use vial is a different way of packaging the same tirzepatide medicine already sold as Mounjaro for type 2 diabetes and Zepbound for weight management. It does not change what the drug does or how it works in the body; the letters describe only additions to labeling, packaging, and instructions for use, not new clinical data on safety or effectiveness ^[1][2].

For patients, a new vial presentation could eventually affect how the medicine is dispensed, drawn up, or stored, since the multi-dose format allows more than one injection to be taken from a single vial rather than using a single-dose vial or a prefilled pen. The letters include new Instructions for Use specific to the multi-dose vial, which patients would need to follow if they receive that version of the product ^[1][2]. However, the source letters do not describe pricing, insurance coverage, or the exact timeline for when the multi-dose vials will appear on pharmacy shelves.

What happens next

Lilly is required to submit final content of labeling in structured product labeling format within 14 days of the approval letters, and final printed carton and container labeling within 30 days after it is printed ^[1][2]. Patent information for the new presentation is due to the FDA within 30 days of approval ^[1][2]. The source documents do not specify a public launch date for the multi-dose vials or say whether they will be available immediately at pharmacies, so that timing is not yet known from these materials.