Chronic Kidney Disease

FDA Approves New Generic for CKD Patients

The US Food and Drug Administration has approved marketing of sevelamer hydrochloride tablets (400 mg and 800 mg), a generic form of Renagel tablets, for control of serum phosphorus levels in patients with chronic kidney disease who are undergoing dialysis.1

Postmarketing adverse reactions associated with the use of sevelamer hydrochloride (Renagel) include hypersensitivity, pruritus, rash, abdominal pain, fecal impaction and uncommon cases of ileus, intestinal obstruction, and intestinal perforation.2

—Michael Potts

References:

  1. Lupin receives U.S. FDA approval for sevelamer hydrochloride tablets. News release. Lupin;June 17, 2021; Accessed June 21, 2021. https://www.lupin.com/lupin-receives-u-s-fda-approval-for-sevelamer-hydrochloride-tablets
  2. US National Library of Medicine, NIH. Renagel tablet. Updated April 22, 2021. Accessed June 21, 2021. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e30120b-f2bf-43a0-86b2-44ae996dc681