Pharma major Lupin Ltd on Friday (April 10) has announced the launch of dapagliflozin tablets in 5 mg and 10 mg strengths in the United States. The launch follows approval of its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (USFDA), the company said.
Lupin stated that the product is bioequivalent to Farxiga for the indications specified in the approved labelling. The tablets have been introduced in the US market after receiving regulatory approval from the US FDA.
This week, Lupin Ltd said it had received approval from the US Food and Drug Administration for its dapagliflozin and metformin hydrochloride extended-release tablets in multiple strengths in the United States.
Also Read: Lupin unit Nanomi to acquire remaining 43.38% stake in Philippines arm for up to $39.6 million
The approval covers tablets in 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg strengths, while a 2.5 mg/1,000 mg variant has received tentative approval.
The approved product is bioequivalent to Xigduo XR and will be used for the same indications as per the approved label, the company said. The development strengthens Lupin’s presence in the US market in the anti-diabetic segment.
Shares of Lupin Ltd ended at ₹2,332.80, up by ₹36.65, or 1.60%, on the BSE today, April 10.
Also Read: Lupin shares may see up to 16% upside post Q3, analysts say — should you buy?
(Edited by : Shoma Bhattacharjee)
