For diabetes mellitus. BLA 761325, held by Sanofi-Aventis U.S. LLC. Insulin Aspart-Szjj.
As of Nov 13, 2026, BLA 761325 (Merilog, Merilog Solostar), held by Sanofi-Aventis U.S. LLC, was first approved by FDA on Feb 14, 2025, with 0 approved supplements and 0 published complete response letters.
MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 14, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Merilog10ML(100UNITS/ML) · injection;solution | Insulin Aspart-Szjj | Rx |
| Merilog Solostar3ML(100UNITS/ML) · injection;solution | Insulin Aspart-Szjj | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
