Lupin Dapagliflozin Tablets gets tentative USFDA okay

Mumbai: Global pharma major Lupin Limited has announced that the Company has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg, and 10 mg to market a generic equivalent of Farxiga Tablets, 5 mg, and 10 mg of AstraZeneca AB. Dapagliflozin Tablets are used for the treatment of type 2 diabetes.

This product will be manufactured at Lupin’s Pithampur facility in India.

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the U.S. (IQVIA MAT September 2023).

Read also: Lupin gets USFDA approval for Ganirelix Acetate Injection

Medical Dialogues team had earlier reported that Lupin had received tentative approval from the USFDA for its Abbreviated New Drug Application for Canagliflozin and Metformin Hydrochloride Extended-Release Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg to market a generic equivalent of Invokamet XR Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg, of Janssen Pharmaceuticals, Inc.