Archive · 7 Nov 2025
Alembic Pharma Receives USFDA Approval for Generic Blood Cancer Drug
A company called Alembic Pharmaceuticals has gotten permission from the US government to sell a new version of a medicine.
This medicine is used to help people who have certain kinds of blood cancer, like leukemia.
It's a copycat version of another medicine that already exists, so it's called a generic.
Getting this permission means they can now sell it in the United States.
The medicine comes in different strengths.
It can be used for adults and also for children who are at least one year old.
This new generic medicine has a big market, with people spending over a billion dollars on the original medicine in a recent year.
Alembic Pharmaceuticals has received final approval from the USFDA for its generic Dasatinib tablets.
The drug is used to treat specific types of blood cancer in adults and children.
The approved generic is therapeutically equivalent to Bristol-Myers Squibb's Sprycel tablets.
The medication is indicated for Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).
The estimated market size for Dasatinib tablets is approximately USD 1,017 million.
- Who
- Alembic Pharmaceuticals Ltd
- What
- Received final approval from the USFDA for its generic version of Dasatinib tablets used to treat certain types of blood cancer.
- When
- Friday, November 7, 2025
- Where
- United States
- Why
- To provide a generic treatment option for specific types of blood cancer, including Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).
- Company
- Alembic Pharmaceuticals Ltd
- Regulator
- US Food & Drug Administration (USFDA)
- Drug Name
- Dasatinib Tablets (Generic)
- Reference Drug
- Sprycel tablets
- Therapeutic Equivalence
- Yes
- Market Size (USD)
- 1,017 million (12 months ended Sept 2025)