AstraZeneca Pharma has received marketing authorisation from the Drug Controller General India DCG(I) for Xigduo XR tablets used in treatment of adults with type II diabetes in India. The product is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type II diabetes. The drug has been approved in 61 countries, including the US, the EU and Japan, and demonstrates an overall favourable benefit risk profile for treatment of patients with type II diabetes. The product is approved with multiple dosage strengths of dapagliflozin and metformin hydrochloride extended-release, respectively, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg.
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