AstraZeneca gets DCGI approval for Dapagliflozin in treatment of heart failure

AstraZeneca Pharma India on Monday said it has received approval for extended indication from the Drugs Controller General of India for Dapagliflozin 10 mg tablets.

The company has received permission from the DCGI to import pharmaceutical formulations of a new drug for sale or distribution for Dapagliflozin Tablets 10 mg, the drug firm said in a regulatory filing. "Through this approval, Dapagliflozin tablets are indicated for the treatment of heart failure in adults," it added.

The receipt of this permission paves the way for the launch of the product in India for the specified indication, subject to the receipt of related statutory approvals and licenses, it said.

The company in a release stated that the DGCI has granted extended indication approval for Dapagliflozin in the treatment of heart failure in adults. Dapagliflozin is mainly used to treat type 2 diabetes. Shares of the company on Monday ended 0.86 per cent down at Rs 3,769.40 apiece on the BSE.

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