Bangalore: AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India to import for sale and distribution of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin), under Brand name Datverzo, which is a new drug in India.
Through this approval, Datverzo is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) (Brand name: Datverzo) in India for the specified indication, subject to the receipt of related statutory approvals, if any.
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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