Lupin Gets US FDA Nod for Sodium Zirconium Cyclosilicate Oral Suspension

Lupin Limited has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension. This approval makes Lupin's product bioequivalent to AstraZeneca's Lokelma® for Oral Suspension, indicated for treating hyperkalemia in adults. The reference drug had estimated annual sales of USD 568 million in the U.S. as of June 2026, presenting a significant market opportunity for Lupin.