Lupin Limited in partnership with Pharmascience Inc. on Monday announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), 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 (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022). The tablets are prescribed to treat certain types of cancer and it works by slowing or stopping the growth of cancer cells.
Shares of Lupin settled at Rs 662.50 apiece, up 1.49 percent on the BSE.
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