FDA approves generic version of cancer drug

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FDA approves generic version of cancer drug

Generics/News | Posted 11/10/2013 0 Post your comment

FDA announced on 16 September 2013 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Roche’s cancer drug Xeloda (capecitabine).

Xeloda is a chemotherapy treatment indicated for use in colorectal cancer and breast cancer that spreads to other parts of the body. The drug had sales of US$1.65 billion in 2012, making it Roche’s fifth-largest drug.

According to the National Cancer Institute, it is estimated that 1.6 million people in the US will be diagnosed with and 580,000 will die of cancer in 2013. Furthermore, an estimated 50,830 people will die of cancer of the colon and rectum and 39,620 women will die of cancer of the breast in 2013.

Dr Kathleen Uhl, Acting Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, said that the approval of Teva’s generic capecitabine would give more cancer sufferers ‘access to affordable treatment options’. She added that ‘generic drugs are important options that allow greater access to health care for all Americans.’

The patent on Xeloda will expire in December 2013. Roche has already made a deal with Indian drugmaker Intas Pharmaceuticals (Intas) in June 2013 allowing Intas to sell generic Xeloda in the US before it loses its exclusivity.

Teva’s generic capecitabine will be available in 150 and 500 mg strengths and will contain a warning (as does the originator) for patients taking medicine used to thin the blood, such as warfarin.

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Source: FDA