Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancers, in the American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dasatinib tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Alembic Pharmaceuticals said in a statement.
The tentatively approved ANDA is therapeutically equivalent to Bristol Myers Squibb Company's Sprycel tablets, it added. Dasatinib Tablet is indicated for the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.
Besides, it is indicated for Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) with resistance or intolerance to prior therapy. As per IQVIA, Dasatinib tablets have an estimated market size of USD 1,465 million for twelve months ending December 2021.
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