Tyzeka

Telbivudine; Sebivo

Tyzeka is indicated for the treatment of chronic hepatitis B in adult patients and was approved for sale in the U.S. in October 2006.

On February 25, 2008, the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use recommended that new warnings be placed on Novartis’ Hepatitis B treatment, Sebivo (sold as Tyzeka in the United States). The warning advises doctors to watch patients treated with the drug for signs of diabetic neuropathy, or a deterioration of the spinal cord and its nerves due to diabetes.

Source: “Warnings coming for Novartis Hepatitis B treatment,” FDAnews Drug Daily Bulletin, February 25, 2008 (http://fdanews.com/newsletter/article?issueId=11339&articleId=104323).