The U.S. Food and Drug Administration (FDA) approved a generic version of Dapagliflozin And Metformin Hydrochloride (ANDA 211491) on April 6, 2026. This approval, sponsored by SUN PHARM., introduces a new option for the combination medication.
Background
Dapagliflozin And Metformin Hydrochloride is a combination drug. Its active components include dapagliflozin and metformin hydrochloride. Other drugs related to this class include canagliflozin and empagliflozin.
What this means
The FDA's approval of a generic version of Dapagliflozin And Metformin Hydrochloride is a significant development for patient access. Generic approvals typically lead to increased availability and potentially more affordable treatment options, expanding choices for patients who require this combination therapy.
Source
The U.S. Food and Drug Administration (FDA) announced the approval of ANDA 211491 for Dapagliflozin And Metformin Hydrochloride on April 6, 2026. This information is publicly available on the accessdata.fda.gov website.