New Delhi, April 7 Aurobindo Pharma announced on Tuesday that it has received final approval from the US health regulator for its generic version of dapagliflozin tablets, which are used to control blood sugar levels in people with type 2 diabetes.
The final approval granted by the US Food & Drug Administration (USFDA) to manufacture and market dapagliflozin tablets is for strengths of 5 mg and 10 mg, Aurobindo Pharma said in a regulatory filing.
These are bioequivalent and therapeutically equivalent to the reference listed drug, AstraZeneca AB's Farxiga tablets, in 5 mg and 10 mg strengths, it added.
These products will be manufactured at Unit-IV of APL Healthcare Ltd, a wholly-owned subsidiary of the company, and will be launched immediately.
Dapagliflozin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Aurobindo Pharma, being one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for dapagliflozin tablets, in 5 mg and 10 mg strengths, is thus eligible for 180 days of shared generic drug marketing exclusivity, the company said.
The approved product has an estimated market size of USD 10.2 billion for the 12 months ending February 2026, according to IQVIA MAT data, the company said.
