Lupin Receives US FDA Approval for Dapagliflozin-Metformin XR

Lupin received US FDA approval for its generic Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in four dosage strengths.
The approval covers 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg formulations as bioequivalent to AstraZeneca's Xigduo XR.
Lupin also received tentative FDA approval for the 2.5 mg/1,000 mg dosage strength of the same combination product.
This regulatory milestone strengthens Lupin's position in the US anti-diabetic pharmaceutical market with a complex generic product.