AstraZeneca Pharma India secures CDSCO nod to import, sell Durvalumab for small cell lung cancer
Bangalore: 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 for sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication.
Through this approval, Durvalumab is indicated for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
The receipt of this permission paves way for the marketing of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
Medical Dialogues team had earlier reported that the Company had received permission from the CDSCO 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).
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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.
