Manages elevated serum phosphorus levels. NDA 21468, held by Takeda Pharms USA. Lanthanum Carbonate.
As of Nov 14, 2026, NDA 21468 (Fosrenol), held by Takeda Pharms USA, was first approved by FDA on Oct 26, 2004, with 16 approved supplements and 0 published complete response letters.
LANTHANUM CARBONATE 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 |
|---|---|---|---|
| Oct 26, 2004 | Original applicationNew molecular entity · Standard review | Approved |
| FosrenolEQ 250MG BASE · tablet, chewable;oral | Lanthanum Carbonate | Discontinued |
| FosrenolEQ 500MG BASE · tablet, chewable;oral | Lanthanum Carbonate | RxReference drug |
| FosrenolEQ 750MG BASE · tablet, chewable;oral | Lanthanum Carbonate | RxReference drug |
| FosrenolEQ 1GM BASE · tablet, chewable;oral | Lanthanum Carbonate | RxReference drug |
| Aug 29, 2024 | Supplement 25Labeling · Standard review | Approved | |
| Dec 12, 2023 | Supplement 24Labeling · Standard review | Approved | |
| May 10, 2023 | Supplement 26Labeling · Standard review | Approved | |
| May 11, 2020 | Supplement 23Labeling · Standard review | Approved | |
| Nov 8, 2018 | Supplement 21Labeling · Standard review | Approved | |
| Feb 24, 2016 | Supplement 20Labeling · Standard review | Approved | |
| Sep 24, 2014 | Supplement 19Labeling · Standard review | Approved | |
| Oct 31, 2012 | Supplement 18Labeling | Approved | |
| Sep 2, 2011 | Supplement 16Labeling | Approved | |
| Apr 27, 2011 | Supplement 15Labeling | Approved | |
| Apr 27, 2011 | Supplement 14Labeling | Approved | |
| Oct 23, 2008 | Supplement 11Labeling · Standard review | Approved | |
| Oct 2, 2008 | Supplement 12Manufacturing | Approved | None posted |
| Apr 10, 2008 | Supplement 10Labeling · Standard review | Approved | |
| Mar 3, 2006 | Supplement 5Labeling · Standard review | Approved | |
| Mar 3, 2006 | Supplement 4Labeling · Standard review | Approved | |
| Oct 26, 2004 | 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
