Global pharmaceutical major Lupin Limited has received approval from the U.S. Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet.

The US FDA has approved Lupin’s product as bioequivalent to Lokelma for Oral Suspension, the reference listed drug marketed by AstraZeneca Pharmaceuticals LP. The product is indicated for the treatment of hyperkalemia in adults.

Sodium Zirconium Cyclosilicate is a potassium-binding agent used to reduce elevated potassium levels in the blood. Lupin’s approval provides the company with an opportunity to participate in the U.S. market for this therapy.

According to IQVIA data cited by the company, U.S. sales of Sodium Zirconium Cyclosilicate for Oral Suspension, with Lokelma® as the reference product, were estimated at USD 568 million for the 12 months ended June 2026.