Roche files Tamiflu for pediatric patients

Tamiflu, which is indicated for the prevention and treatment of influenza types A and B in patients one year and older, is currently available in a 75mg capsule for adults as well as liquid suspension formulation for children.

With a longer shelf life than the liquid suspension formulation, Tamiflu pediatric capsules provide a better option for government pandemic stockpiling and can be administered to children for seasonal influenza. Research indicates that children are especially vulnerable to influenza and its complications.

The application was filed based on information already available for the 75mg capsule. The only change will be the size of the capsule and the amount of the active ingredient, oseltamivir phosphate, filled into the capsule. Roche is optimistic that the FDA will complete its review of the application by mid-2007.

According to Roche, when taken within 12-48 hours of symptom onset, antiviral medications like Tamiflu can help reduce the duration of symptoms. Tamiflu can be used preventively to help avoid the flu altogether. Clinical trials have shown Tamiflu to be up to 89% effective in preventing influenza illness when taken within 48 hours of exposure.