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AstraZeneca Pharma gets nod to import, market Acalabrutinib tablets 100 mg

The company has received permission from the Central Drugs Standard Control Organisation

AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Acalabrutinib tablets 100 mg (Brand name: Calquence) for an additional indication.

Through this approval, Acalabrutinib tablets 100 mg in combination with venetoclax with or without obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) /small lymphocytic lymphoma (SLL).

The receipt of this permission paves way for the marketing of Acalabrutinib tablets 100 mg (Brand name: Calquence) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.

AstraZeneca Pharma India is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.