AstraZeneca gets DCGI nod for Dapagliflozin tablets to treat chronic kidney disease
New Delhi: AstraZeneca Pharma India on Saturday said it has received approval from the Drugs Controller General of India (DCGI) for Dapagliflozin tablets for the treatment of patients with chronic kidney disease.
The company has "received Import and Market Permission in Form CT-20 (Subsequent New Drug Approval) from the DCGI for Dapagliflozin tablets 10 mg," AstraZeneca Pharma India said in a filing to BSE.
Dapagliflozin tablet 10 mg is now approved for additional indication, for the treatment of patients with chronic kidney disease(CKD) up to Stage III, it added.
The receipt of this permission paves way for the launch of the product into a new disease area to nephrologists in India, the filing said.
In July 2020, the company had said that it has received DCGI nod for Dapagliflozin tablets for treatment of patients suffering from heart failure with reduced ejection fraction.
The drug is also sold in the country as a diabetic medicine used for lowering blood sugar in adults with type 2 diabetes.