The U.S. Food and Drug Administration (FDA) approved a generic version of Dapagliflozin and Metformin Hydrochloride on 2026-04-06. This approval, granted to Aurobindo Pharma under Abbreviated New Drug Application (ANDA) 211489, makes a bioequivalent alternative to the brand-name combination product, Xigduo XR, available to the market.
Background
Dapagliflozin and Metformin Hydrochloride is a combination medication. The brand-name product, Xigduo XR, combines dapagliflozin and metformin hydrochloride. The approval of a generic version by the FDA, specifically ANDA 211489 sponsored by Aurobindo Pharma, signifies that the new product has demonstrated bioequivalence to the reference listed drug. This ensures that the generic version is comparable in quality, safety, and efficacy to the original brand-name product.
What this means
The FDA's approval of a generic version of Dapagliflozin and Metformin Hydrochloride, a combination drug known by its brand name Xigduo XR, is a significant development for patients and healthcare providers. Generic approvals typically lead to increased market competition, which can result in more affordable treatment options and broader access to essential medications. This approval by Aurobindo Pharma provides an additional, bioequivalent choice for managing conditions for which the combination drug is indicated. The availability of generic alternatives is a key component of efforts to reduce healthcare costs and improve patient access to necessary therapies.
Source
The information regarding this initial FDA approval for Dapagliflozin and Metformin Hydrochloride (ANDA 211489) was obtained from the U.S. Food and Drug Administration (FDA). The approval, granted to Aurobindo Pharma, was officially recorded on 2026-04-06 and is publicly accessible on the accessdata.fda.gov website, specifically through the FDA's Approved Drug Products database.