AstraZeneca Pharma India has received an import and market permission in Form CT-20 (subsequent new drug approval) from the Central Drugs Standard Control Organisation for Dapagliflozin tablets of 10 mg.
Through this approval, the Company is permitted to deal in Dapagliflozin (Forxiga®) tablets of 10 mg in additional/expanded indication to reduce the risk of sustained eGFR and kidney disease, cardiovascular death and hospitalization for heart failure in adult with chronic kidney disease at risk of progression with condition.
The additional condition is that it is indicated in adults for the treatment of patients of chronic kidney disease (CKD) up to eGFR of greater than or equal to 25ml/min/1.73m2.
Below this, initiation of the treatment is not recommended however the patients may continue 10mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF.
The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional or expanded indication, subject to the receipt of related statutory approvals.
