India-based global pharmaceutical company Lupin Limited (BSE:500257) (NSE:LUPIN) announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg and 10 mg.
The FDA approved Lupin's Dapagliflozin Tablets, 5 mg and 10 mg, as bioequivalent to Farxiga for the indications in the approved labelling.
Farxiga, a brand of biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (NYSE:AZN), is indicated for the treatment of type 2 diabetes, chronic kidney disease, and symptomatic chronic heart failure.
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