AstraZeneca Pharma India Limited has received an Import and Market permission in Form CT-20 (Subsequent New Drug Approval) from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India for Dapagliflozin (Forxiga) tablets of 10 mg - additional indication.

 

Through this approval, the company is permitted to deal in Dapagliflozin (Forxiga) tablets of 10 mg in additional/expanded indication “to reduce the risk of sustained eGFR and kidney disease, cardiovascular death and hospitalization for heart failure in adult with chronic kidney disease at risk of progression” with condition that it is indicated in adults for the treatment of patients of chronic kidney disease (CKD) up to eGFR of greater than or equal to 25ml/min/1.73m2. 

 

Below this, initiation of the treatment is not recommended however the patients may continue 10mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF.

 

The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals. 

 

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.