AstraZeneca Pharma Gets CDSCO Nod To Import New Drug For Hyperkalaemia Treatment

The permission paves way for the launch of sodium zirconium cyclosilicate powder for oral suspension 5 g and 10 g (Lokelma) in India.

The Central Drugs Standard Control Organisation (CDSCO) granted approval to import and sell sodium zirconium cyclosilicate powder for oral suspension (Representational. Photo: AstraZeneca Pharma India website)

AstraZeneca Pharma India Ltd. has received approval from the drug regulator to import and sell sodium zirconium cyclosilicate powder for oral suspension, used to treat hyperkalaemia — high potassium levels in the blood — in adults.

The Central Drugs Standard Control Organisation has granted permission to import pharmaceutical formulations of sodium zirconium cyclosilicate powder for oral suspension in 5 g and 10 g doses (Lokelma), according to a regulatory filing on Thursday.

"The receipt of this permission paves way for the launch of sodium zirconium cyclosilicate powder for oral suspension 5 g and 10 g (Lokelma) in India for the above specified indications, subject to the receipt of related statutory approvals," it added.

Earlier in February, AstraZeneca announced that it received a nod from the CDSCO for the sale of cancer treatment medicine Durvalumab solutions. The approval from the CDSCO is for import, sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication.

Shares of AstraZeneca closed 1.73% higher at Rs 7,466.65 apiece on the National Stock Exchange, compared to a 0.93% advance in the benchmark Nifty. The stock has fallen 38.39% in the last 12 months.

(With PTI Inputs)

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