Alembic Pharma gets USFDA tentative approval for cancer drug Bosutinib 400 mg

• Alembic Pharmaceuticals received USFDA tentative approval for Bosutinib Tablets, 400 mg, on January 12.
• The drug is therapeutically equivalent to Bosulif Tablets, 400 mg, used for Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML).
• This 400 mg dosage adds to existing final approvals for 100 mg and 500 mg strengths.
• The market size for Bosutinib Tablets, 400 mg, was estimated at $251 million in the US for the 12 months ending September 2025.
• Alembic Pharma now has 232 cumulative USFDA approvals, reinforcing its presence in the US generics market.

Why It Matters: Alembic Pharma secures USFDA tentative approval for a key cancer treatment drug, expanding its US market presence.