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FDA approves Relypsa's Veltassa

October 22, 2015 1:00 AM UTC

FDA approved Veltassa patiromer ( RLY5016) from Relypsa Inc. (NASDAQ:RLYP) to treat hyperkalemia. The approval comes with a black box warning that recommends against taking Veltassa within six hours of other oral medications. The high-capacity oral potassium binder binds to many orally administered drugs, potentially reducing their effects. Veltassa must be dispensed with a patient medication guide.

Relypsa said it expects to launch Veltassa in the U.S. by the first week of January 2016. The company did not respond to inquiries about pricing. In August, Relypsa granted Sanofi (Euronext:SAN; NYSE:SNY) two years of U.S. co-promotion rights for the drug. ...