Chugai announces new approval for Rocephin

Chugai Pharmaceutical has announced that its antibiotic Rocephin (ceftriaxone) has had its approval extended to include once-daily administration in children.

The compound is a cephalosporin antibiotic for injection that was developed by F Hoffmann-La Roche in 1978 and first launched in Japan in 1986.

It exhibits a strong antibacterial activity against a wide spectrum of bacteria with high clinical efficacy.

The compound is recommended as a first-line treatment for infectious diseases, including meningitis, biliary tract infection, community-acquired pneumonia and gonococcal infection both inside and outside Japan.

Chugai forecasts that the compound is also expected to produce an effect on recently-emerged drug-resistant Streptococcus pneumoniae and Haemophilus influenzae bacteria.

Rocephin has had its approval extended under the Handling of Ethical Drugs concerning Off-Label Use notification following submissions by the company.

“Rocephin has been the only cephalosporin injection drug available for once daily administration in adults,” the company reports.

“However, this newly approved dosage, once daily administration in children, will make possible the reduction in dosing frequency during hospital stay, thereby avoiding patients’ burden of late-night administration as well as reducing healthcare workers’ burden.”

In July 2007, Roche issued a letter to physicians warning of the potential risk to infants relating to injectable Rocephin following reports of fatalities in babies both full-term and premature receiving calcium within two days of being administered with the drug.