BioCentury
ARTICLE | Company News

FDA drops Veltassa's black box warning

November 28, 2016 10:09 PM UTC

The Relypsa Inc. unit of Vifor Pharma Ltd. (Zurich, Switzerland) said FDA approved an sNDA that removes a black box warning from the label of Veltassa patiromer. The warning addressed potential drug-drug interactions, and recommended against taking the hyperkalemia drug within six hours of other oral medications. The new label recommends that patients take Veltassa at least three hours before or after other oral medications.

FDA approved Veltassa, a high-capacity oral potassium binder, in October 2015. In May, Relypsa submitted the sNDA with results of Phase I drug-drug interaction studies that showed absorption was not affected for any of 12 tested drugs when taken three hours apart from Veltassa (see BioCentury Extra, Jan. 25)...

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