Date: 19-Oct-2026
Regulatory Authority: US Food and Drug Administration (USFDA)
Applicant: Fresenius Medical Care Renal Therapies Group, LLC
the US Food and Drug Administration (USFDA) approved two new drug applications (NDAs) submitted by Fresenius Medical Care Renal Therapies Group, LLC for Calrezdy (calcium chloride solution) and Cienby (sodium citrate solution). Both products are intended for use in regional citrate anticoagulation (RCA) during continuous renal replacement therapy.
Key Approval Details
1. Calrezdy (Calcium Chloride Solution)
Calrezdy was approved under NDA 219456 for calcium substitution during regional citrate anticoagulation in adults and pediatric patients weighing 40 kg or more undergoing continuous venovenous hemodialysis (CVVHD) or continuous venovenous hemodiafiltration (CVVHDF).
2. Cienby (Sodium Citrate Solution)
Cienby was approved under NDA 219455 for regional citrate anticoagulation during CVVHD or CVVHDF in adults and pediatric patients weighing 40 kg or more.
Regulatory Significance
Both applications were submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The FDA approval letters identify the products as combination products and specify postmarketing safety reporting obligations. The approved solutions are intended for extracorporeal use with the multiFiltratePRO system, which is cleared for patients weighing 40 kg or more.
These approvals expand the available product options for specialized anticoagulation management during continuous renal replacement therapy.
Source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219456Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219455Orig1s000ltr.pdf