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Broad-spectrum Oral Antibacterial Agent Gracevit(R) Tablets 50 mg/fine granules 10% Receives Approval for Manufacturing and Marketing Print E-mail
28 Jan 2008

DAIICHI SANKYO COMPANY, LIMITED announced it received approval on January 25 for its broad-spectrum antibacterial agent Gracevit(R) from the Japanese Ministry of Health, Labour and Welfare

TOKYO, Japan | January 28, 2008 | DAIICHI SANKYO COMPANY, LIMITED (hereafter; DAIICHI SANKYO) announced it received approval on January 25 for its broad-spectrum antibacterial agent Gracevit(R) (generic name: sitafloxacin hydrate) from the Japanese Ministry of Health, Labour and Welfare. Gracevit(R) is to be marketed in 50 mg tablet form and as a 10% fine granular preparation.

DAIICHI SANKYO currently markets Cravit(R), which is in the same class as Gracevit(R), in tablet form and as a fine granular preparation. Cravit(R) is highly acclaimed for its clinical efficacy and safety. However, Gracevit(R) exhibits potent antibacterial activity with a broad spectrum and DAIICHI SANKYO expects it to be clinically effective in severe cases of bacterial infection, relapse/recrudescence of infection and infections where resistant bacteria are the suspected cause. The anticipated Gracevit(R) can be prescribed as the new quinolone oral antibacterial agent.

Promoting drug compliance and ensuring safety for Gracevit(R) are top priorities for DAIICHI SANKYO and the company is set to provide information for these purposes. In addition to Cravit(R), DAIICHI SANKYO is confident Gracevit(R) can further contribute to the treatment of infectious diseases.

SOURCE: DAIICHI SANKYO





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