Lupin gets US FDA nod for sodium zirconium cyclosilicate
The drug is bioequivalent to AstraZeneca’s Lokelma and indicated for hyperkalaemia in adults
Lupin has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet, the company announced.
The US 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. The product is indicated for the treatment of hyperkalaemia in adults.
Sodium Zirconium Cyclosilicate for Oral Suspension (RLD Lokelma) had estimated annual sales of USD 568 million in the US, according to IQVIA MAT June 2026.