Controls serum phosphorus levels. NDA 205109, held by Vifor Fresenius. Ferric Oxyhydroxide.
As of Nov 15, 2026, NDA 205109 (Velphoro), held by Vifor Fresenius, was first approved by FDA on Nov 27, 2013, with 8 approved supplements and 0 published complete response letters.
Velphoro is indicated for the control of serum phosphorus levels in adults and pediatric patients 6 years of age and older with chronic kidney disease (CKD) on dialysis.
| Oct 13, 2026 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jul 1, 2024 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Nov 27, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| VelphoroEQ 500MG IRON · tablet, chewable;oral | Ferric Oxyhydroxide | RxReference drug |
| VelphoroEQ 250MG IRON · tablet, chewable;oral | Ferric Oxyhydroxide | RxReference drug |
| Oct 13, 2026 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Aug 27, 2024 | Supplement 10Labeling · Standard review | Approved | |
| Jul 1, 2024 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Feb 28, 2020 | Supplement 8Labeling · Standard review | Approved | |
| Apr 25, 2018 | Supplement 6Labeling · Standard review | Approved | |
| Aug 3, 2017 | Supplement 5Labeling · Standard review | Approved | |
| Jun 12, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 24, 2014 | Supplement 1Labeling · Standard review | Approved | |
| Nov 27, 2013 | Original applicationNew formulation or manufacturer · 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
