Lupin Receives US FDA Approval for Dapagliflozin Tablets

Lupin Limited received U.S. FDA approval for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg and 10 mg.
The approval confirms the tablets as bioequivalent to AstraZeneca's Farxiga® for all indications in the approved labeling.
This regulatory milestone allows Lupin to commercialize a generic version of a major anti-diabetic drug in the U.S. market.
The approval strengthens Lupin's position in the U.S. pharmaceutical market and its portfolio in the anti-diabetic therapy area.