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New Delhi, Nov 7 (PTI) Alembic Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic version of Dasatinib tablets used to treat certain types of blood cancer. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dasatinib Tablets of strengths 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Alembic Pharmaceuticals said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS), it added. 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; and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy, it added. The company further said Dasatinib tablets are also indicated for the treatment of pediatric patients one year of age and older with Ph+ CML in chronic phase. Citing IQVIA data, Alembic Pharmaceuticals said Dasatinib tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, have an estimated market size of USD 1,017 million for 12 months ended September 2025. PTI RKL MR MR
