Lupin receives tentative approval from USFDA for Dasatinib Tablets

Lupin receives tentative approval from USFDA for Dasatinib Tablets

By: IPP Bureau

Last updated : August 29, 2022 10:05 pm



Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).


Global pharma major Lupin Limited (Lupin) in partnership with Pharmascience Inc. today 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).

Lupin Limited Lupin Dasatinib Tablets

First Published : August 29, 2022 12:00 am