Alembic Pharmaceuticals announces USFDA Tentative Approval for Bosutinib Tablets, 100 mg and 500 mg

1 July 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) 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. Refer label for a detailed indication.

Bosutinib Tablets 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.