CDSCO gives nod to Dapagliflozin Tablets

Through this approval, the company is permitted to deal in Dapagliflozin (Forxiga) tablets of 10 mg for the additional/expanded indications.

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CDSCO DCGI FDA

Last Updated on November 30, 2022 by The Health Master

Bangalore: AstraZeneca Pharma India Limited has announced that the company has received import and marketing permission in Form CT-20 (subsequent new drug approval) from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, for dapagliflozin (Forxiga) tablets of 10 mg, – additional indication.

Through this approval, the company is permitted to deal in Dapagliflozin (Forxiga) tablets of 10 mg for the following additional/expanded indications:

“To reduce the risk of sustained eGFR and kidney disease, cardiovascular death and hospitalization for heart failure in an adult with chronic kidney disease at risk of progression” with conditions 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 the 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,” the company stated in a BSE filing.

AstraZeneca India was established in 1979 and is headquartered in Bengaluru, Karnataka. AstraZeneca Pharma India Limited (AZPIL) is the operating company and covers the manufacturing, sales, and marketing activities of the company in India.

The company has an innovative portfolio in crucial areas of healthcare, including cardiovascular, renal & metabolic diseases, oncology, and respiratory. It is a listed company and is a subsidiary of AstraZeneca Plc, UK.

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