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FDA removes boxed warning from Relypsa’s Veltassa
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The U.S. Food and Drug Administration has approved a supplemental New Drug Application for Relypsa Inc.’s Veltassa (patiromer), which removes the boxed warning regarding the separation of Veltassa and other oral medications from the label. The updated label recommends patients take Veltassa at least three hours before or three hours after other oral medications. This information is now detailed in the dosage and administration section and the drug interactions section of the label. Data from the Veltassa drug-drug interaction program has been added to the Clinical Pharmacology section of the label.
The FDA approved Veltassa to treat hyperkalemia on Oct. 21, 2015.
“We are extremely pleased the FDA has approved these changes to Veltassa’s label, including removal of the Boxed Warning. These important updates are based on our positive data, which showed there is a low risk for drug-drug interactions with Veltassa when it is separated from other oral medications by at least 3 hours,” said John A. Orwin, president and chief executive officer of Relypsa. “We believe the 3-hour dose separation and addition of data from our drug-drug interaction program to the label can provide doctors greater flexibility in choosing Veltassa and adding it to patients’ daily treatment regimen.”