USFDA gives tentative nod to Alembic Pharma’s generic formulation to treat leukemia

Bosutinib Tablets have an estimated market size of US$ 275 million for twelve months ending March 2024 according to IQVIA.

July 1, 2024 12:01 IST

USFDA gives tentative nod to Alembic Pharma's generic formulation to treat leukemia

Bosutinib tablets are indicated for the treatment of a certain type of leukemia. (Image Credits: Pixabay)

Alembic Pharmaceuticals Limited on Monday 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.

According to the company’s statement, 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).

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