For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Takashi Shoda, President and Representative Director
(Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Toshiaki Sai, General Manager,
Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/
Daiichi Sankyo Obtains Manufacturing and Marketing Approval for new Cravit® Formulations
TOKYO, Japan (April 22, 2009) -Daiichi Sankyo Company, Limited (TSE: 4568), today obtained manufacturing and marketing approval in Japan for new formulations of Cravit® (generic name: Levofloxacin Hydrate), a broad-spectrum oral anti-bacterial agent. These formulations are 250mg and 500mg tablets, and a 10% fine granular preparation.
Since its introduction in December 1993, Cravit® has gained approval for treating 43 indications and 32 bacteria. This agent continues to offer outstanding efficacy, and has won accolades for its safety profile.
Daiichi Sankyo drew on PK-PD theory (see note below) to develop the once-daily dosage for the 500mg Cravit® tablet. This tablet lifts the maximum blood concentration and is significantly more bactericidal than the 100mg formulation, taken three times daily, suppressing the development of drug-resistant bacteria. The once-daily dosage of the Cravit® 500mg tablet is an approved standard in more than 120 countries and territories.
Daiichi Sankyo has accumulated years of expertise in the infectious diseases field, and is convinced that the Cravit® will contribute even more in treatment of infections.
Note: PK-PD theory
This is a scientifically proven concept for design the optimal administrations of anti-bacterial agents.
This anti-bacterial efficacy and safety assessment concept combines pharmacokinetics (PK), which shows how anti-bacterial agent concentration changes within human body, and pharmacodynamics (PD), considers the actions of anti-bacterial agents within organisms.
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