DGCI has approved an extended indication of dapagliflozin for the treatment of adults with heart failure, the company said in a press release
Post Date – 23rd Monday 24th July 11:15pm
New Delhi: AstraZeneca Pharmaceuticals India said on Monday that it has received approval from the Drug Regulatory Agency of India for the expanded indication of dapagliflozin 10 mg tablet.
The pharmaceutical company said in a regulatory filing that it has received a license from DCGI to import a pharmaceutical formulation of a new drug for sale or distribution of 10 mg dapagliflozin tablets.
“With this approval, Dapagliflozin Tablets can be used to treat heart failure in adults,” it added.
Obtaining this clearance will pave the way for the launch of the product in India for specific indications, subject to the relevant statutory approvals and clearances, the company said.
The DGCI has approved an extended indication for dapagliflozin for the treatment of adults with heart failure, the company said in a release. Dapagliflozin is mainly used to treat type 2 diabetes.
Shares of the company closed down 0.86 per cent at Rs 3,769.40 a share on the BSE on Monday.
