CDSCO nod to AstraZeneca Pharma India to import, sell lung cancer treatment medicine
AstraZeneca Pharma India has announced that the Company has received permission from the CentralDrugs Standard Control Organisation, 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 in combination with Tremelimumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC). 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.
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.
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Medical Dialogues team had earlier reported that the Company had received permission to import for sale and distribution of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion from the CDSCO for lung cancer treatment, subject to the receipt of related statutory approvals, if any. Durvalumab in combination with chemotherapy as neoadjuvant treatment, followed by Durvalumab as monotherapy after surgery, was indicated for the treatment of patients with resectable (tumours 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
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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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