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Lupin gets USFDA’s tentative nod for Canagliflozin Tablets

23 Nov 2023 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Canagliflozin Tablets, 100 mg and 300 mg, to market a generic equivalent of Invokana Tablets, 100 mg and 300 mg, of Janssen Pharmaceuticals, Inc. 

This product will be manufactured at Lupin’s Pithampur facility in India. Canagliflozin Tablets (RLD Invokana) had estimated annual sales of $561 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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