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).
