Pharma giant Lupin Ltd announced on Friday (April 10) the launch of dapagliflozin tablets in 5 mg and 10 mg doses in the United States. This launch comes after receiving approval for its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (USFDA), according to the company.
Lupin noted that this product is bioequivalent to Farxiga for the specified indications outlined in the approved labeling. The tablets are now available in the US market following regulatory approval from the US FDA.
Earlier this week, Lupin Ltd announced that it had obtained approval from the US Food and Drug Administration for its dapagliflozin and metformin hydrochloride extended-release tablets in various strengths in the United States.
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The approval includes tablets in strengths of 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg, while a 2.5 mg/1,000 mg version has received tentative approval.
This approved product is bioequivalent to Xigduo XR and will be utilized for the same indications as stated in the approved label, the company stated. This development enhances Lupin’s position in the US market within the anti-diabetic sector.
Shares of Lupin Ltd concluded at ₹2,332.80, reflecting an increase of ₹36.65, or 1.60%, on the BSE today, April 10.
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(Edited by : Shoma Bhattacharjee)
