Lupin receives tentative US FDA approval for Dasatinib tablets

Lupin, in partnership with Pharmascience Inc, has received tentative approval from the US 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, according to a statement from Lupin.

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of $1,569 million in the US (IQVIA MAT June 2022), the statement added.