Alembic Gets USFDA Nod for Dasatinib Tablets in Six Strengths

Alembic Pharmaceuticals Limited (Alembic), a pharmaceutical company engaged in vertically integrated research and development, has announced that it has obtained final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) concerning dasatinib tablets in dosages 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, available in the same dosages of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, produced by Bristol-Myers Squibb Company (BMS).

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 Dasatinib tablets are indicated for the treatment of adult patients with: (i) newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in the chronic phase, (ii) chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML who exhibit resistance or intolerance to prior therapies including imatinib, and (iii) Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) with resistance or intolerance to previous treatments.

 Additionally, dasatinib tablets are indicated for the treatment of paediatric patients aged 1 year and older who have Ph+ CML in the chronic phase.

 Dasatinib tablets in dosages of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg are projected to have a market size of approximately US$ 1,017 million for the twelve months ending in September 2025, as reported by IQVIA.

 Alembic has achieved a cumulative total of 227 ANDA approvals, which includes 207 final approvals and 20 tentative approvals, from the US FDA.