Lupin gets tentative nod for Dapagliflozin Tablets from USFDA

21 Nov 2023 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) 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. This product will be manufactured at Lupin’s Pithampur facility in India. Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of $7282 million in the U.S. (IQVIA MAT September 2023).  

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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