Alembic receives US tentative approval for Dasatinib tablets

alembic

Alembic Pharmaceuticals today announced receiving tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib tablets, 20 mg, 50 mg, 70
mg, 80 mg, 100 mg, and 140 mg.

Dasatinib tablet is prescribed for the treatment of adult patients with newly
diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase.

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The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product Sprycel tablets, 20 mg, 50 mg,
70 mg, 80 mg, 100 mg, and 140 mg, of Bristol Myers Squibb Company.

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Dasatinib tablets had an estimated market size of $1,465 million for the 12 months ending December 2021.