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Daiichi Sankyo wins approval for new formulations of antibiotic drug

Daiichi Sankyo Company has obtained manufacturing and marketing approval in Japan for new formulations of Cravit, a broad-spectrum oral antibacterial 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, the company said.

Daiichi Sankyo drew on PK-PD theory 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, according to the company. The once-daily dosage of the Cravit 500mg tablet is an approved standard in more than 120 countries and territories, the company added.