The FDA's drug approvals database lists a supplement to NDA 215866 for Mounjaro (tirzepatide), held by Eli Lilly. The record carries no action date and does not say what the supplement covers. The same sweep also lists a supplement for Zepbound, which is another tirzepatide product.
There is nothing in either entry that indicates a new indication, a safety communication or a label change, and the database does not describe supplements in detail. For prescribers, the useful step is to read the current product information. The FDA is the authority cited here; the entry says nothing about the products' status with CDSCO.
- The FDA entry lists a supplement; its content and date are not given.
- Read the current product information for tirzepatide before relying on remembered prescribing details.
- No change to tirzepatide prescribing is indicated by the entry alone.
Why it matters
A supplement can be anything from paperwork to a labelling change, and the record does not say which.
Don't overread it
A supplement listed without detail is not a new indication or a safety warning.
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