On Monday, Alembic Pharmaceuticals Ltd announced that it has obtained tentative approval for generic Ribociclib tablets, which are utilized in breast cancer treatment, during the March quarter.
According to a regulatory filing, the tentative approval from the US Food & Drug Administration (USFDA) pertains to Ribociclib tablets with a strength of 200 mg.
This medication is prescribed for adult patients diagnosed with a specific type of advanced or metastatic breast cancer, in combination with other drug therapies.
The filing further stated that it is the generic counterpart of Novartis’ Kisqali tablets.