Roche files sNDA for pediatric Tamiflu doses

Swiss drug major Roche's US subsidiary has filed a supplemental New Drug Application with the Food and Drug Administration to market its flu drug Tamiflu (oseltamivir phosphate) capsules in pediatric doses of 30mg and 45mg. 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 (five years versus 24 months), Tamiflu pediatric capsules provide a better option for government pandemic stockpiling and can be administered to children for seasonal influenza, the company says.

The application was filed based on information already available for the 75mg capsule. The method of manufacturing will remain the same; the only change will be the size of the capsule and the amount of the active ingredient filled into the capsule. Roche says it is optimistic that the FDA will complete its review of the sNDA by mid-2007.