Overview
Lanthanum carbonate is a phosphate binder commonly used in clinical practice. It is marketed under the trade name Fosrenol by Shire Pharmaceuticals. It is the largest of all pills filled in community pharmacies. Sometimes patients forget that Fosrenol is not swallowed whole, but instead should be chewed. This has led to severe choking. It is prescribed for treating high phosphate levels, mainly found in patients with chronic kidney disease. Lanthanum should be taken with meals and binds to phosphate in the diet, preventing phosphate absorption in the intestine.
Indication
Used to reduce serum phosphate in patients with end stage renal disease (ESRD).
Associated Conditions
- Hyperphosphataemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/03/01 | Phase 4 | Completed | |||
2017/11/17 | Phase 3 | UNKNOWN | |||
2017/05/02 | Phase 1 | Completed | |||
2017/03/08 | Phase 1 | Completed | |||
2014/10/07 | Phase 2 | Completed | |||
2014/09/11 | Phase 4 | UNKNOWN | |||
2014/08/06 | Phase 4 | Completed | |||
2013/05/03 | Phase 4 | UNKNOWN | |||
2012/10/01 | Phase 2 | Completed | |||
2012/04/20 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0093-5938 | ORAL | 500 mg in 1 1 | 2/7/2024 | |
| Takeda Pharmaceuticals America, Inc. | 54092-252 | ORAL | 500 mg in 1 1 | 12/20/2023 | |
| Exelan Pharmaceuticals, Inc. | 76282-477 | ORAL | 750 mg in 1 1 | 6/13/2023 | |
| Takeda Pharmaceuticals America, Inc. | 54092-254 | ORAL | 1000 mg in 1 1 | 12/20/2023 | |
| Takeda Pharmaceuticals America, Inc. | 54092-253 | ORAL | 750 mg in 1 1 | 12/20/2023 | |
| Exelan Pharmaceuticals, Inc. | 76282-476 | ORAL | 500 mg in 1 1 | 6/13/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-819 | ORAL | 500 mg in 1 1 | 1/22/2024 | |
| Teva Pharmaceuticals USA, Inc. | 0093-5940 | ORAL | 1000 mg in 1 1 | 2/7/2024 | |
| Cipla USA Inc. | 69097-936 | ORAL | 1000 mg in 1 1 | 6/13/2023 | |
| Prasco Laboratories | 66993-422 | ORAL | 500 mg in 1 1 | 12/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Fosrenol Chewable Tablets 500mg | SIN13594P | TABLET, CHEWABLE | 500mg | 1/23/2009 | |
| Fosrenol Chewable Tablets 1000mg | SIN13596P | TABLET, CHEWABLE | 1000mg | 1/23/2009 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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