Alembic Pharma bags USFDA tentative nod for Bosutinib Tablets to treat certain type of leukemia
Vadodara: 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 Bosutinib
Tablets, 100 mg and 500 mg.
The approved ANDA is therapeutically equivalent to the
reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism
C.V. (PF Prism).
Bosutinib tablets are indicated for the treatment of a certain type of
leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia. It is a type of cancer that affects the blood and bone marrow. It is characterized by the presence of a specific genetic abnormality known as the Philadelphia chromosome.
Bosutinib Tablets, 100 mg and 500 mg have an estimated market size of US$ 275
million for twelve months ending March 2024 according to IQVIA.
Alembic has a cumulative total of 206 ANDA approvals (179 final approvals and 27
tentative approvals) from USFDA.
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Headquartered in India, Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Its state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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