Lupin scores major US breakthrough with FDA nod for key diabetes drug
By: IPP Bureau
Last updated : April 10, 2026 2:55 pm
The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
In a significant regulatory win, global pharmaceutical giant Lupin has secured approval from the US FDA for its key diabetes drug.
The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets.
The approval spans four dosage combinations—5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg—marking a key expansion of Lupin’s diabetes treatment portfolio in the US market.
In addition, the company has received tentative approval for the 2.5 mg/1,000 mg variant, positioning it for future launch pending final clearance.
Crucially, the US FDA confirmed that Lupin’s formulation is bioequivalent to Xigduo XR, allowing it to be prescribed for the same indications outlined in the approved labeling.
The development strengthens Lupin’s foothold in the highly competitive diabetes care segment, signaling continued momentum in its US generics pipeline.