FDA approves two efficacy supplements for Eli Lilly's Mounjaro
The agency cleared supplement numbers 44 and 45 for tirzepatide's NDA on the same status date, with labeling updated in early September 2026.
The FDA approved two efficacy supplements to Eli Lilly's Mounjaro (tirzepatide, NDA215866), designated submission numbers 44 and 45. Both are classified as an efficacy submission and were marked approved with a submission status date of 2026-08-271, a status also confirmed for supplement 45 in its own filing record.
The approval letter covering both supplements is dated August 28, 2026, and applies jointly to submissions s044 and s045, as shown in the application docs listing an approval letter dated 20260828 for both filings. Updated product labeling was posted on September 1, 2026, per the label document dated 20260901 in both supplements' records. Supplement 45's file also includes a Medication Guide, posted the same date and linked to page 27 of the label document2.
Both supplements cover Lilly's full existing Mounjaro product line. The approvals apply across the subcutaneous solution formulations sold as Mounjaro, Mounjaro KwikPen, and Mounjaro (Autoinjector), spanning tirzepatide strengths from 2.5MG/0.5ML up to 60MG/2.4ML (25MG/ML)1, as listed in both filings' product tables. Eli Lilly and Co is the sponsor, and review priority for both submissions is listed as standard.1
The documents do not specify the clinical content of the labeling changes tied to these two efficacy supplements beyond confirming their approval and associated document dates. Readers seeking the specific indication or label language changes should consult the linked FDA approval letter and label PDF, dated August 28 and September 1, 2026, respectively, as cited above.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.