Alembic Pharmaceuticals Ltd on Monday announced that it received tentative approval for generic Ribociclib tablets used in the treatment of breast cancer in the March quarter.
The tentative approval by the US Food & Drug Administration (USFDA) was for Ribociclib tablets of strength 200 mg, Alembic Pharmaceuticals said in a regulatory filing.
According to the company’s statement, the medicine is indicated for the treatment of adult patients with a certain type of advanced or metastatic breast cancer in a combination of drug therapies.
It is the generic equivalent of Novartis’ Kisqali tablets, the filing added.