CDSCO nod to AstraZeneca to import, sell hyperkalaemia treatment drug in India
AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 for Sodium Zirconium Cyclosilicate powder for oral suspension 5 g and 10 g (Lokelma).
Through this approval, Sodium Zirconium Cyclosilicate is indicated for the treatment of hyperkalaemia in adult patients. Hyperkalemia is a condition in which serum or plasma potassium levels exceed the normal upper limit, typically above 5.0 to 5.5 mEq/L. While mild cases may not present symptoms, severe hyperkalemia can lead to serious health risks, including life-threatening cardiac arrhythmias, muscle weakness, and even paralysis.
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, if any
Medical Dialogues team had ealier reported that AstraZeneca Pharma India had received CDSCO nod to import for sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication of unresectable hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a type of liver cancer. Because symptoms often don’t appear until the advanced stages, getting diagnosed with liver cancer like HCC can come as a shock.
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AstraZeneca India was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited is the operating company and covers manufacturing, sales and marketing activities of the company in India.
It is a listed company and is a subsidiary of AstraZeneca Plc, UK.
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