Alembic Pharmaceuticals gets FDA approval for Dasatinib Tablets

Alembic Pharmaceuticals has secured tentative approval for the abbreviated new drug application (ANDA) of Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg from the US Food and Drug Administration (FDA).

The tentatively approved product is the generic of Bristol Myers Squibb Company’s Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

Dasatinib Tablet is indicated for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. It is approved for use in adult patients only.

According to IQVIA, Dasatinib Tablets have an estimated market size of $1.46bn for 12 months ending December 2021.