FDA approves efficacy supplement for Vifor Fresenius's Velphoro

The U.S. Food and Drug Administration approved Supplement 14 to the New Drug Application for Velphoro (ferric oxyhydroxide), a chewable tablet, under NDA205109. The submission is classified as an efficacy supplement and carries submission status "AP," meaning approved, with a status date of October 13, 2026.¹

Velphoro is sponsored by Vifor Fresenius, and the approved product is formulated as a chewable tablet taken orally, with each tablet containing the equivalent of 500 mg of iron as ferric oxyhydroxide.¹

The FDA's review of this submission was handled under standard review priority, rather than priority review.¹ The agency's approval letter for this supplement is dated October 15, 2026, according to the application's associated correspondence record.

The document does not specify what clinical or labeling changes the efficacy supplement covers, nor does it detail any new trial data, dosing changes, or indication updates associated with Supplement 14. No additional context on the regulatory history of Velphoro or related submissions is included in this record.

Readers seeking further detail on the substance of the approved supplement, such as updated labeling language or supporting clinical evidence, would need to consult the FDA's approval letter directly or additional agency documentation, as the drug application record itself does not elaborate beyond the administrative and product details listed above.