AstraZeneca gets CDSCO panel nod to Market Dapagliflozin to treat heart failure in adult
New Delhi: Pharmaceutical major, AstraZeneca has got a go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to import and market Dapagliflozin tablet 10mg for the treatment of heart failure in adults.
This came after the firm presented the proposal for the import and marketing of Dapagliflozin tablet 10mg for the additional indication i.e. for the treatment of heart failure in adults.
Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine.
Dapagliflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in adults with type 2 diabetes (a condition in which blood sugar is too high because the body does not produce or use insulin normally). It is also used to reduce the risk of needing to be hospitalized for heart failure in adults who have type 2 diabetes along with heart and blood vessel disease or who have multiple risk factors for developing heart and blood vessel disease.
Dapagliflozin is also used in adults with heart failure to reduce the risk of needing to be hospitalized and death due to heart and blood vessel disease. It is also used to reduce the risk of worsening kidney disease, the need to be hospitalized for heart failure, and the risk of death due to heart disease in adults with kidney disease.
At the recent SEC meeting for Cardiovascular and Renal held on 24th May 2023, the expert panel reviewed the proposal presented by Pharmaceutical major AstraZeneca for the import and marketing of Dapagliflozin tablet 10mg for the additional indication i.e. for the treatment of heart failure in adults.
The expert panel noted that the firm in support of the additional indication presented the global clinical trial data along with the justification of the local clinical trial waiver.
In addition to the above, the committee noted that the proposed indication for the Dapagliflozin tablet 10mg has been approved in around 55 countries.
After detailed deliberation, the committee recommended the grant of permission for the import and marketing of Dapagliflozin tablet 10mg for the additional indication i.e. for the treatment of heart failure in adults.
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