Treats hypertension. NDA 219878, held by Astrazeneca AB. Baxdrostat.
As of Nov 13, 2026, NDA 219878 (Baxfendy), held by Astrazeneca AB, was first approved by FDA on May 15, 2026, with 0 approved supplements and 0 published complete response letters.
BAXFENDY, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction of these events with BAXFENDY.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Baxfendy1MG · tablet;oral | Baxdrostat | RxReference drug |
| Baxfendy2MG · tablet;oral | Baxdrostat | RxReference drug |
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
