AstraZeneca gets regulator’s nod to sell diabetes drug

Press Trust of India New Delhi | Updated on January 08, 2018

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

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

The tablet, a product of the AstraZeneca Group, has been approved in 61 countries, including the US, EU 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 will 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,” AstraZeneca India 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, AstraZeneca Pharma India said.

Published on October 17, 2017

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