Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, 10 mg/1,000 mg. The company also received tentative approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 2.5 mg/1,000 mg.
The US FDA has approved Lupin’s Dapagliflozin and Metformin Hydrochloride Extended-Release tablets as bioequivalent to Xigduo XR for the indications in the approved labeling.