Alembic Pharmaceuticals Receives USFDA Final Approval for Dasatinib Tablets

Alembic Pharmaceuticals Limited has received US Food & Drug Administration (USFDA) Final Approval for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, of Bristol-Myers Squibb Company. Dasatinib tablets are indicated for the treatment of adult patients with 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, Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are also indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. The estimated market size of Dasatinib Tablets is USS 1,017 million for twelve months ending September 2025 according to IQVIA.