For diabetes mellitus. BLA 208157, held by Baxter Hlthcare Corp. Insulin Human.
As of Nov 13, 2026, BLA 208157 (Myxredlin), held by Baxter Hlthcare Corp, was first approved by FDA on Jun 20, 2019, with 2 approved supplements and 0 published complete response letters.
MYXREDLIN is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Myxredlin100 UNITS/100ML (1 UNIT/ML) · solution;intravenous | Insulin Human | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 2025 | Supplement 8Labeling · Standard review | Approved | |
| Jun 4, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Jun 20, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
