The U.S. Food and Drug Administration (FDA) granted approval for a generic version of Dapagliflozin and Metformin Hydrochloride (ANDA 211479) on April 6, 2026. This approval was granted to sponsor MSN, marking an important step for increased patient access to this combination medication.
Background
An Abbreviated New Drug Application (ANDA) approval signifies that a generic drug is bioequivalent to its reference listed drug (RLD). Generic versions are typically approved after the expiration of patents and exclusivities on the brand-name drug, aiming to provide more affordable treatment options. Dapagliflozin is part of a class of drugs known as SGLT2 inhibitors, while metformin hydrochloride is a biguanide. Other related SGLT2 inhibitors include canagliflozin and empagliflozin.
What this means
The approval of a generic version of Dapagliflozin and Metformin Hydrochloride by the FDA is expected to enhance market competition and potentially lower healthcare costs for patients. Generic drugs offer the same quality, strength, purity, and stability as their brand-name counterparts, providing equivalent therapeutic effect at a potentially reduced price point. This development can improve access to this important combination therapy for individuals who may benefit from it.
Source
The information regarding this approval was sourced from the U.S. Food and Drug Administration (FDA) website, specifically their database for Abbreviated New Drug Applications. The approval for ANDA 211479 was recorded on April 6, 2026, on accessdata.fda.gov.