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.
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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.
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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.