AstraZeneca gets CDSCO Panel Nod To Import, Market Sodium Zirconium Cyclosilicate Powder for Oral Suspension
New Delhi: Noting an unmet medical need, the Subject ExperCommittee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major AstraZeneca to import and market Sodium Zirconium Cyclosilicate powder for oral suspension (Lokelma 5g and 10g).
However, this approval is subject to a condition that the drug major AstraZeneca should conduct a Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug.
This nod came after AstraZeneca presented the proposal for a grant of permission to import and market Sodium Zirconium Cyclosilicate powder for oral suspension 5g & 10g along with justification for a clinical trial waiver before the committee.
Sodium zirconium cyclosilicate is in a class of medications called potassium-removing agents. Sodium zirconium cyclosilicate is used to treat hyperkalemia (high potassium in the blood). This medicine is a potassium binder. It should not be used as an emergency treatment for life-threatening hyperkalemia. This medicine is available only with your doctor's prescription.
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