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AstraZeneca Pharma India gets DCGI nod to market diabetes drug

The company, however, did not share the price at which it would be selling the tablets

Press Trust of India  |  New Delhi 

drugs, medicines, USFDA

Pharma has received marketing authorisation from the Drug Controller General of (DCGI) for Xigduo XR tablets used in treatment of adults with type 2 in

The product is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes, Pharma said in a statement.

The tablet, a product of the Group, has been approved in 61 countries, including the US, and Japan, and demonstrates an overall favourable benefit risk profile for treatment of patients with type 2 diabetes, it added.

The company, however, did not share the price at which it would be selling the tablets.

"Xigduo XR will provide physicians and patients with an advanced treatment option that provides better glycemic control, potential weight loss and the reduced risk of hypoglycemia," Medical Affairs & Regulatory Head Anilda Dsouza said.

With these tablets the company is able to offer physicians a personalised and effective treatment option to manage the type 2 diabetes, Dsouza said.

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, Pharma said.

The starting dose can be individualised based on each patient's current treatment regimen, it added.

Shares of Pharma today closed at Rs 951 per scrip on BSE, up 0.11 per cent from its previous close.

First Published: Tue, October 17 2017. 19:16 IST