Lupin launches Dapagliflozin and Metformin extended-release tablets in the United States
USFDA approves ANDA for bioequivalent version of Xigduo XR
Lupin announced the launch of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in strengths of 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg in the United States.
The launch follows the approval of its Abbreviated New Drug Application by the U.S. Food and Drug Administration. The product is approved as bioequivalent to Xigduo XR for the indications in the approved labelling.