Treats hyperkalemia. NDA 207078, held by Astrazeneca. Sodium Zirconium Cyclosilicate.
As of Nov 14, 2026, NDA 207078 (Lokelma), held by Astrazeneca, was first approved by FDA on May 18, 2018, with 4 approved supplements and 0 published complete response letters.
LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
| Apr 24, 2020 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| May 18, 2018 | Original applicationNew molecular entity · Standard review | Approved |
| Lokelma5GM/PACKET · for suspension;oral | Sodium Zirconium Cyclosilicate | RxReference drug |
| Lokelma10GM/PACKET · for suspension;oral | Sodium Zirconium Cyclosilicate | RxReference drug |
| Feb 8, 2024 | Supplement 10Labeling · Standard review | Approved | |
| Sep 30, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Oct 19, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Apr 24, 2020 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| May 18, 2018 | Original applicationNew molecular entity · 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
