For diabetes mellitus. BLA 761412, held by Sunshine Lake Pharma Co Ltd. Insulin Glargine-Aldy.
As of Nov 13, 2026, BLA 761412 (Langlara), held by Sunshine Lake Pharma Co Ltd, was first approved by FDA on Apr 29, 2026, with 0 approved supplements and 0 published complete response letters.
LANGLARA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Langlara100UNITS/ML · injectable;subcutaneous | Insulin Glargine-Aldy | 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
