Vadodara: Alembic Pharmaceuticals Limited has announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) 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, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS).

Dasatinib tablets are indicated for the treatment of adult patients with:

(i) newly diagnosed Philadelphia chromosomepositive (Ph+) chronic myeloid leukemia (CML) in chronic phase,

(ii) chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib,

(iii) Philadelphia ch

See Full Page