Controls serum phosphorus. NDA 22318, held by Genzyme. Sevelamer Carbonate.
As of Nov 13, 2026, NDA 22318 (Renvela), held by Genzyme, was first approved by FDA on Aug 12, 2009, with 5 approved supplements and 0 published complete response letters.
Sevelamer carbonate is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
| Nov 25, 2016 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Aug 12, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Renvela800MG/PACKET · for suspension;oral | Sevelamer Carbonate | DiscontinuedReference drug |
| Renvela2.4GM/PACKET · for suspension;oral | Sevelamer Carbonate | DiscontinuedReference drug |
| Apr 30, 2020 | Supplement 12Labeling · Standard review | Approved | |
| Nov 25, 2016 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Mar 9, 2016 | Supplement 6Labeling · Standard review | Approved | |
| Nov 26, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Jun 16, 2011 | Supplement 3Labeling | Approved | |
| Aug 12, 2009 | 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
