Last Updated on October 6, 2024 by The Health Master
Global pharma major Lupin Limited (Lupin), in partnership with Pharmascience Inc., announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA).
This ANDA approval is for dasatinib tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, to market a generic equivalent of Sprycel tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company.
Dasatinib tablets (Sprycel) had estimated annual sales of USD 1569 million in the US (IQVIA MAT June 2022).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.
The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
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