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AstraZeneca Pharma receives approval for Dapagliflozin from DCGI

 

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AstraZeneca Pharma receives approval for Dapagliflozin from DCGI

AstraZeneca Pharma India Limited has received Permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from the Drugs Controller General of India for Dapagliflozin Tablets 10 mg.

Dapagliflozin Tablets 10mg is indicated for the treatment of heart failure in adults. Forxiga (dapagliflozin) was developed by Bristol-Myers Squibb and AstraZeneca. It belongs to a class of drugs known as SGLT2 (sodium-glucose cotransporter 2) inhibitors.

Forxiga works by inhibiting the SGLT2 protein in the kidneys. This protein plays a role in the reabsorption of glucose back into the bloodstream. By blocking SGLT2, Forxiga helps the kidneys excrete excess glucose through urine, thus reducing blood glucose levels.

Forxiga was first approved for medical use by the European Medicines Agency (EMA) in November 2012.  The U.S. Food and Drug Administration (FDA) approved dapagliflozin under the brand name Farxiga in January 2014.


In 2020, The FDA approved Farxiga to reduce the risk of cardiovascular death or hospitalization in heart failure patients with a reduced ejection fraction (HFrEF) and with or without Type 2 diabetes.