Manages elevated serum phosphorus levels. NDA 204734, held by Takeda Pharms USA. Lanthanum Carbonate.
As of Nov 13, 2026, NDA 204734 (Fosrenol), held by Takeda Pharms USA, was first approved by FDA on Sep 24, 2014, with 6 approved supplements and 0 published complete response letters.
FOSRENOL is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2014 | Original applicationNew dosage form · Standard review | Approved |
| FosrenolEQ 750MG BASE · powder;oral | Lanthanum Carbonate | RxReference drug |
| FosrenolEQ 1GM BASE · powder;oral | Lanthanum Carbonate | RxReference drug |
| Aug 29, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Dec 12, 2023 | Supplement 6Labeling · Standard review | Approved | |
| May 10, 2023 | Supplement 8Labeling · Standard review | Approved | |
| May 11, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Nov 8, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Feb 24, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Sep 24, 2014 | 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
