Alembic Pharma Gets Tentative USFDA Nod For Breast Cancer Drug

Alembic Pharmaceuticals Ltd on Monday said it received tentative approval for generic Ribociclib tablets used in the treatment of breast cancer in the March quarter.

The tentative approval by the U.S. Food & Drug Administration was for Ribociclib tablets of strength 200 mg, Alembic Pharmaceuticals said in a regulatory filing.

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 therapy.

It is the generic equivalent of Novartis' Kisqali tablets, the filing added.