Lupin Receives US FDA Approval for Sodium Zirconium Cyclosilicate Oral Suspension
Lupin Limited announced US FDA approval for its Sodium Zirconium Cyclosilicate for Oral Suspension. The drug is bioequivalent to Lokelma® and treats hyperkalemia in adults. The U.S. market for the RLD had estimated annual sales of USD 568 million.
FDA approval of a drug formulation with significant market sales potential can have a material impact on the company's revenue and market share in the US.
The US FDA approval of a new drug formulation is a positive development for the company, indicating successful product development and regulatory compliance.
Lupin Limited has announced that it has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Sodium Zirconium Cyclosilicate for Oral Suspension, in 5 g/packet and 10 g/packet strengths.
This approval signifies that Lupin's Sodium Zirconium Cyclosilicate for Oral Suspension is bioequivalent to the reference listed drug (RLD), Lokelma® for Oral Suspension, marketed by AstraZeneca Pharmaceuticals LP. The drug is indicated for the treatment of hyperkalemia in adults.
The U.S. market for Sodium Zirconium Cyclosilicate for Oral Suspension (RLD Lokelma®) had estimated annual sales of USD 568 million as of June 2026, according to IQVIA data.
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See the model portfoliosA plain-language summary of a public exchange filing by Lupin Limited. Read the original for the full detail.