India-based global pharmaceutical company Lupin Limited (BSE:500257) (NSE:LUPIN) announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet.
The product has been approved as bioequivalent to the reference listed drug (RLD), AstraZeneca's Lokelma for Oral Suspension LP, and is indicated for the treatment of hyperkalaemia in adults.
Sodium Zirconium Cyclosilicate for Oral Suspension (RLD Lokelma) had estimated annual sales of USD568m in the US (IQVIA MAT June 2026).
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