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FDA Approves Supplemental New Drug Application for Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions
Posted 30 Nov 2016 by Drugs.com
REDWOOD CITY, Calif., November 27, 2016 – Relypsa, Inc., a Vifor Pharma company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) with important updates to the label of Veltassa (patiromer) for oral suspension. Veltassa’s label no longer includes a Boxed Warning regarding the separation of Veltassa and other oral medications. The updated label recommends patients take Veltassa at least 3 hours before or 3 hours after other oral medications. This information is now detailed in the dosage and administration section (Section 2) and the drug interactions section (Section 7) of the label. In addition, data from the Veltassa drug-drug interaction program has been added to the Clinical Pharmacology section of the label (Section 12). “We are extremely pleased the FDA has approved these changes to Veltassa’s label, includi ... Read more
Posted 28 Oct 2015 by Drugs.com
October 21, 2015 – The U.S. Food and Drug Administration today approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. “Too much potassium in the blood can lead to dangerous, even fatal, changes in heart rhythm,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have treatment options for hyperkalemia available to patients.” Potassium, a mineral that is delivered to the body by food, is needed for cells to function properly. The kidneys remove potassium from the blood to maintain a proper balance of potassium in the body. But when the kidneys are not able to remove enough potassium from the blood, the level of potassium can get too high. Hyperkalemia typically occurs in ... Read more