Inventia enters the U.S. market with FDA approved Dapagliflozin tablets

Inventia Healthcare Limited announced that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application (ANDA) for Dapagliflozin tablets, 5 mg and 10 mg. The company has commenced Day-One commercialisation in the United States.

The FDA determined that Inventia’s dapagliflozin tablets, 5 mg and 10 mg, are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Farxiga (dapagliflozin) tablets, 5 mg and 10 mg (NDA 202293) of AstraZeneca.

The approved indications include reducing the risk of hospitalisation for heart failure in adults with Type 2 Diabetes Mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. It is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Dr. Pavan Bhat, MD, Chief Executive Officer, Inventia Healthcare, said, “With this approval and Day-One launch, we are advancing our commitment to improving access to high-quality, affordable medicines in the U.S.,” said Dr. Pavan Bhat, MD, Chief Executive Officer, Inventia Healthcare. “This milestone reflects the strength of our regulatory capabilities, manufacturing readiness, and patient-first focus.”

According to IQVIA MAT December 2025 data, dapagliflozin tablets recorded annual sales of approximately US$10.5 billion in the United States.

Inventia stated that, with this approval, it is eligible for 180 days of shared generic drug exclusivity for dapagliflozin tablets, 5 mg and 10 mg, subject to applicable statutory provisions.

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