Alembic Pharmaceuticals gets USFDA approval

11 Jun 2022 , 03:38 AM

Alembic Pharmaceuticals has received 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 The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product RLD Sprycel Tablets 20 mg 50 mg 70 mg 80 mg 100 mg and 140 mg of Bristol Myers Squibb Company BMS Dasatinib Tablet is indicated for the treatment of adult patients with i newly diagnosed Philadelphia chromosome-positive 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 chromosome-positive acute lymphoblastic leukemia Ph ALL with resistance or intolerance to prior therapy