AstraZeneca Pharma India gets DCGI nod to market diabetes drug

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 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," 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, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg, AstraZeneca Pharma India said.

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

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