Drug Approval | April 08, 2026
Aurobindo Pharma wins USFDA approval for generic Xigduo XR
Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually
Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually
The product is approved as bioequivalent to Xigduo XR for the indications outlined in the reference drug’s labelling
The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets
Subscribe To Our Newsletter & Stay Updated
