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# Relypsa sNDA Approved for Veltassa Label Update
- URL: https://www.fdaweb.com/relypsa-snda-approved-for-veltassa-label-update/
- Published: 2018-05-08T12:00:00.000Z
- Updated: 2026-09-15T00:03:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141387

FDA has approved a Relypsa supplemental NDA for Veltassa (patiromer) for oral suspension in treating hyperkalemia. The label update is based on results from the Phase 4 TOURMALINE study, which showed no statistically significant difference between the groups taking Veltassa with or without food in achieving serum potassium levels within the target range (3.8 to 5.0 mEq/L), according to the company. “In the TOURMALINE study, 87.3% of the Veltassa with food group and 82.5% of the Veltassa without food group achieved potassium levels in the target range at either week three or week four,” it says. “Patients with higher baseline potassium values generally had greater potassium reductions.”