Lupin has received approval from the United States Food and Drug Administration (USFDA) 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 USFDA has approved the company’s Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets as bioequivalent to Xigduo XR for the indications in the approved labeling.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
