Daiichi Sankyo seeks wider indication for Cravit in Japan

Japanese drug major Daiichi Sankyo (TYO: 4568) has submitted a supplemental New Drug Application (sNDA) in Japan for the synthetic broad-spectrum oral antibacterial agent Cravit (levofloxacin hemihydrate) for the treatment of pulmonary and other tuberculosis disorders.

In Japan, around 20,000 people are newly diagnosed as tuberculosis each year. Some patients, however, do not continue treatment using first-line drugs because of resistance of bacteria to or drug intolerance. By taking levofloxacin in combination with other anti-tuberculosis drugs, it is expected that such refractory tuberculosis can be effectively treated.

Requested to file the application by therapy societies