Mumbai, Nov. 7 -- The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, of Bristol-Myers Squibb Company (BMS). Dasatinib is indicated for 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 is also approved for pediatric patients aged one year and above with Ph+ CML in chronic phase.

According to IQVIA, Dasatinib tablets have an estimated market size of US$ 1,017 m...