AstraZeneca Pharma India gets Dapagliflozin 10mg import and market permission from CDSCO

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Pharma India has secured an import and market permission for Dapagliflozin (Forxiga) tablets of 10 mg from India’s Central Standard Control Organisation (CDSCO), Directorate General of Health Services.

Following the approval, Pharma India is now allowed to deal in Dapagliflozin 10 mg in additional/expanded indication for lowering the risk of sustained eGFR and kidney disease, cardiovascular (CV) death, as well as hospitalization for heart failure in adults having chronic kidney at risk of progression.

Dapagliflozin 10 mg is indicated in India in adults for the treatment of patients with chronic kidney disease (CKD) up to eGFR of more than or equal to 25ml/min/1.73m2. Under this, initiation of the treatment is not recommended but the patients can continue 10mg orally daily once to cut down the risk of eGFR decline, ESKD, CV death, and hHF, said Pharma India.

The subsidiary said that the receipt of the permission enables the launch of Dapagliflozin tablets of 10 mg in India for the specified additional/expanded indication, which will be contingent on securing related statutory approvals.

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