Alembic Pharma has announced that it has received final approval from the US Food & 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.
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), manufactured by Bristol-Myers Squibb Company (BMS), said a statement from the Gujarat-based drug manufacturer.
Dasatinib Tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase, as well as those with chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML who are resistant or intolerant to prior therapy, including imatinib.
They are also indicated for adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant or intolerant to prior therapy.
In addition, Dasatinib Tablets are approved for the treatment of pediatric patients aged 1 year and older with Ph+ CML in the chronic phase, said the statement.
According to IQVIA data, Dasatinib Tablets (20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg) had an estimated market size of USD 1,017 million for the twelve months ending September 2025.
With this approval, Alembic now holds a cumulative total of 227 ANDA approvals (comprising 207 final approvals and 20 tentative approvals) from the USFDA, added the statement. Alembic manufactures and markets generic pharmaceutical products all over the world.
