The pharmaceutical company on Friday announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib tablets.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Sprycel Tablets of Bristol Myers Squibb Company (BMS).
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Followed by, chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Furthermore, Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
According to IQVIA, Dasatinib Tablets have an estimated market size of $1465 million for twelve months ending December 2021.
Alembic Pharmaceuticals has a cumulative total of 168 ANDA approvals (144 final approvals and 24 tentative approvals) from USFDA.
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Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
On a consolidated basis, the company reported a 39.7% fall in net profit to Rs 176.42 crore on a 3.2% fall in net sales to Rs 1,271.7 crore in Q4 FY22 over Q4 FY21.
Shares of Alembic Pharmaceuticals were up 0.21% to Rs 733.65 on the BSE.
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