NAPLES, Fla. — Global pharma major Lupin today announced that it 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, 5 g/packet and 10 g/packet.
The U.S. FDA has approved Lupin's Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet as bioequivalent to the reference listed drug (RLD) Lokelma for Oral Suspension of AstraZeneca Pharmaceuticals LP and is indicated for the treatment of hyperkalemia in adults.
Sodium Zirconium Cyclosilicate for Oral Suspension (RLD Lokelma) had estimated annual sales of USD 568 million in the U.S. (IQVIA MAT Jun 2026).
