Natco had earlier submitted an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) to market GSK’s generic version of Tykerb 250mg tablets.
Tykerb tablets are indicated as a treatment for certain types of advanced or metastatic breast cancer and are used in combination with another medicine (capecitabine or letrozole).
Tykerb is a protein-tyrosine kinase inhibitor which works by preventing the growth of cancer cells.