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Sevelamer hydrochloride approval date?

See the DrugPatentWatch profile for Sevelamer

When was sevelamer hydrochloride approved?

Sevelamer hydrochloride (brand name Renagel) received FDA approval in 1998 for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. [1]

Was the approval for a specific use or population?

Yes. The approval was for lowering phosphorus levels in patients with end-stage renal disease (or chronic kidney disease) on dialysis, as part of managing hyperphosphatemia. [1]

How does this relate to sevelamer carbonate (Renvela)?

Sevelamer hydrochloride and sevelamer carbonate are different salt forms of sevelamer, marketed under different brand names (Renagel vs. Renvela). Their approval timelines and labeling can differ because they are distinct drug products. [1]

Source

[1] https://www.drugpatentwatch.com/patent/Sevelamer%20Hydrochloride



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