Shandong Xinhua Pharmaceutical Gets Marketing Go-Ahead for Hyperphosphatemia Drug from FDA

MT Newswires Live

2024/11/26

Shandong Xinhua Pharmaceutical (HKG:0719, SHE:000756) recently received a drug registration approval letter for its sevelamer carbonate from the US Food and Drug Administration, a Monday Hong Kong bourse filing said.

The marketing of sevelamer carbonate (active pharmaceutical ingredients) has been approved following the completion of a review of the relevant drug master file.

Sevelamer carbonate is used to control hyperphosphatemia in adult patients with chronic kidney disease who are undergoing dialysis.

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