Alembic Pharmaceuticals said in a statement it had received approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Dasatinib tablets of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg.

It added that the preliminary approved ANDA is therapeutically equivalent to Bristol Myers Squibb’s Sprycel tablets. Dasatinib is indicated for treating newly diagnosed Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukaemia (CML) chronic phase, accelerated phase, or myeloid or lymphoid blast phase Ph+ CML in response or resistance to prior therapy, including imatinib.

Additionally, it is indicated for Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia (Ph+ ALL) that is resistant or intolerant to prior therapy. According to IQVIA, the market size for Dasatinib tablets was estimated at $1,465 billion in the twelve months to December 2021.