Lupin receives US FDA approval for Dapagliflozin tablets

Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin tablets, 5 mg and 10 mg.

The U.S. FDA has approved Lupin’s Dapagliflozin tablets, 5 mg and 10 mg, as bioequivalent to Farxiga for the indications in the approved labelling.