Astrazeneca Pharma receives DCGI approval for launch of diabetes drug in India

Astrazeneca Pharma India has received Import and Market permission in Form 45 (Marketing Authorization) from the Drugs Controller General of India for FDC of Dapagliflozin 10mg + Saxagliptin 5mg film coated tablets.

The receipt of this Import and Market permission paves way for the launch of FDC of Dapagliflozin 10mg + Saxagliptin 5mg film coated tablets (QTERN) in India, subject to the receipt of other related statutory approvals and licenses.

FDC of Dapagliflozin 10mg + Saxagliptin 5mg is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus (T2DM).

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