AstraZeneca Pharma India Receives Permission for Durvalumab Sale and Distribution

AstraZeneca Pharma India Ltd. has announced that it has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India for the sale and distribution of Durvalumab 120mg/2.4 ml and 500mg/10 ml solution for infusion (Imfinzi) in India. This permission is for an additional indication: 'Durvalumab (IMFINZI) in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements'. The launch of Durvalumab is subject to the receipt of related statutory approvals, if any.