Archive · 12 Jan 2026
Alembic Gets USFDA Tentative Approval for Cancer Drug
Alembic Pharmaceuticals, an Indian company, got a special approval from the US health authorities for a medicine called Bosutinib.
This medicine is used to treat a type of blood cancer called chronic myelogenous leukemia (CML) in adults.
The approval is for a 400 mg version of the drug.
Alembic already had approval for 100 mg and 500 mg versions of the same drug.
The USFDA said this new version is just as good as the original medicine made by another company.
This is good news because it means more people might be able to get this important cancer treatment.
Alembic Pharmaceuticals received tentative USFDA approval for its 400 mg Bosutinib tablets.
The approval is for a supplemental abbreviated new drug application (sANDA).
Bosutinib is used to treat adult patients with chronic phase Ph+ CML, newly-diagnosed or resistant/intolerant to prior therapy.
It is also indicated for accelerated or blast phase Ph+ CML with resistance/intolerance to prior therapy.
Alembic had previously received final approval for 100 mg and 500 mg versions of Bosutinib.
- Who
- Alembic Pharmaceuticals Ltd
- What
- Received tentative approval from the USFDA for its Bosutinib tablets (400 mg)
- When
- January 12, 2026
- Where
- United States
- Why
- For the treatment of certain types of cancer, specifically chronic phase Ph+ CML and accelerated or blast phase Ph+ CML
- Company
- Alembic Pharmaceuticals Ltd
- Drug
- Bosutinib tablets (400 mg)
- Approval Type
- Tentative approval for sANDA
- Regulator
- US Food & Drug Administration (USFDA)
- Reference Drug
- Bosulif tablets (400 mg) by PF Prism CV
- Indications
- Treatment of adult patients with chronic phase Ph+ CML, newly-diagnosed or resistant/intolerant to prior therapy; also for accelerated or blast phase Ph+ CML with resistance/intolerance to prior therapy
- Previous Approvals
- Final approval for Bosutinib tablets (100 mg and 500 mg)
- Date
- January 12, 2026