Aurobindo pharma receives USFDA nod for two Dapagliflozin tablets

HYDERABAD: Aurobindo Pharma on Tuesday said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market two diabetes treatments — Dapagliflozin as well as Dapagliflozin and Metformin Hydrochloride extended-release tablets — in the United States.The company has received the US drug regulator’s approval for Dapagliflozin 5 mg and 10 mg tablets as well as Dapagliflozin and Metformin Hydrochloride ER tablets in 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg and 10 mg/1000 mg strengths.The approvals will help expand Aurobindo’s generics portfolio in the US with the products that are generic versions of AstraZeneca’s Farxiga and Xigduo XR, respectively.Both the products will be manufactured at Unit-IV of APL Healthcare Ltd, a wholly owned subsidiary of Aurobindo Pharma, and will be launched immediately, the company said.According to IQVIA MAT data for the 12 months ending Feb 2026, the approved generic version of Xigduo XR addresses an estimated market of $514 million, while the approved generic version of Farxiga targets a market estimated at $10.2 billion.Aurobindo said it was among the first abbreviated new drug application applicants to submit substantially complete ANDAs with paragraph IV certifications for both products, making it eligible for 180 days of shared generic drug exclusivity in each case.As of March 31, 2026, Aurobindo Pharma had 579 ANDA approvals from the USFDA, including 554 final approvals and 25 tentative approvals.