Treats severe hypoglycemia. NDA 210134, held by Amphastar Pharms Inc. Glucagon.
As of Nov 14, 2026, NDA 210134 (Baqsimi), held by Amphastar Pharms Inc, was first approved by FDA on Jul 24, 2019, with 2 approved supplements and 0 published complete response letters.
BAQSIMI is indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes.
| Mar 17, 2025 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jul 24, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Baqsimi3MG · powder;nasal | Glucagon | RxReference drug |
| Mar 17, 2025 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Oct 27, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Jul 24, 2019 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
