New Launch22 Apr 2026, 09:12 am
Lupin Launches Dapagliflozin & Metformin XR Tablets in US
AI Summary
Global pharma major Lupin Limited announced the launch of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in the United States. This follows the U.S. FDA's approval for its Abbreviated New Drug Application (ANDA), confirming bioequivalence to Xigduo® XR. The tablets are available in various strengths: 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg. This launch enhances Lupin's product portfolio in the anti-diabetic therapy area within the crucial U.S. market.
Key Highlights
- Lupin launched Dapagliflozin & Metformin XR tablets in the US.
- The launch follows US FDA approval for its ANDA.
- The drug is bioequivalent to AstraZeneca's Xigduo® XR.
- Strengthens Lupin's anti-diabetic portfolio in the US market.