AstraZeneca heart failure drug Dapagliflozin gets DCGI approval
The company has received import and market permission from DCGI in Form CT-20 (Marketing Authorisation- Additional Indication). The receipt of the permission paves the way for the launch of Dapagliflozin film-coated tablet 10mg in India, AstraZeneca Pharma India said.;
New Delhi: Drug firm AstraZeneca Pharma India on Saturday said it has received approval from Drugs Controller General of India (DCGI) for Dapagliflozin tablets for the treatment of patients suffering from heart failure with reduced ejection fraction.
The company has received import and market permission from DCGI in Form CT-20 (Marketing Authorisation- Additional Indication). The receipt of the permission paves the way for the launch of Dapagliflozin film-coated tablet 10mg in India, AstraZeneca Pharma India said.
The drug is already being sold in the country as a diabetic medicine used for lowering blood sugar in adults with type 2 diabetes.
"This is the first in class SGLT-2 inhibitor drug approved for the treatment of heart failure with reduced ejection fraction (HFrEF) and is the first drug proven to significantly reduce the risk of cardiovascular death and hospitalization for heart failure in patients with HFrEF," the company said in a statement.
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