USFDA nod to Alembic Pharma cancer drug Dasatinib

Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company 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. 

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Dasatinib Tablets have an estimated market size of US$ 1465 million for twelve months ending Dec 2021 according to IQVIA.

Alembic has a cumulative total of 168 ANDA approvals (144 final approvals and 24 tentative approvals) from USFDA.

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