The U.S. Food and Drug Administration (FDA) granted initial approval to a generic version of Dapagliflozin and Metformin Hydrochloride on 2026-04-06. This approval, designated as Abbreviated New Drug Application (ANDA) 211559, was granted to MACLEODS PHARMS LTD., expanding access to this combination medication.
Background
Dapagliflozin and Metformin Hydrochloride is a combination product. The individual components, dapagliflozin and metformin hydrochloride, are established pharmaceutical agents. The approval of a generic version means that the reference listed drug (RLD) for this combination product has previously been approved by the FDA. Related drugs include canagliflozin and empagliflozin.
What this means
The FDA's approval of a generic Dapagliflozin and Metformin Hydrochloride product by MACLEODS PHARMS LTD. is significant for increasing patient access and potentially lowering healthcare costs. Generic drugs are typically more affordable than their brand-name counterparts and are required to be bioequivalent to their reference listed drug, ensuring comparable safety and efficacy. This approval introduces a new, cost-effective option for clinicians and patients.
Source
The information regarding this initial generic approval was obtained from the U.S. Food and Drug Administration (FDA). The approval for Dapagliflozin and Metformin Hydrochloride (ANDA 211559) was recorded on 2026-04-06 and is accessible via the FDA's website, accessdata.fda.gov.