The drug maker 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.
The company said it "has received an Import and Market permission in Form CT-20 (Subsequent New Drug Approval) from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India for Dapagliflozin (Forxiga) tablets of 10 mg - additional indication."The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals.
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 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.
Astrazeneca Pharma India is engaged in the business of manufacture, distribution and marketing of pharmaceutical products and also provides clinical trial services to an overseas group company.
The company's standalone net profit surged 172.5% to Rs 32.56 crore on 19.4% jump in revenue from operations to Rs 236.13 crore in Q2 FY23 over Q2 FY22.
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