FDA approves efficacy supplement for Lilly's Zepbound (tirzepatide)
The agency signed off on submission 41 for NDA217806, with a corrected approval letter and label dated September 10, 2026.
The FDA has approved a new efficacy supplement for Eli Lilly's Zepbound, according to agency records. The submission is listed as SUPPL 41 under application number NDA217806, sponsored by Eli Lilly and Co, and classified as an efficacy submission with standard review priority.1
The submission's status date is recorded as August 26, 2026, and the associated application documents, a corrected approval letter and a corrected label, are dated September 10, 2026.
Zepbound is formulated as tirzepatide, a subcutaneous solution, and the FDA record lists an extensive range of approved strengths and delivery devices. Products include Zepbound and Zepbound KwikPen presentations ranging from 2.5MG/0.5ML up to 60MG/2.4ML, as well as Zepbound autoinjector versions in strengths from 2.5MG/0.5ML to 15MG/0.5ML.1
The record does not specify which clinical indication or label change triggered this efficacy supplement, nor does it describe trial data or endpoints tied to the approval. No additional milestones or forthcoming regulatory actions are noted in the filing beyond the approval itself.
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