ROCHE FILES SNDA FOR PEDIATRIC TAMIFLU
Roche has filed a supplemental new drug application (sNDA) with the FDA to market Tamiflu capsules in pediatric doses of 30 and 45 mg. Last month the company submitted a similar application in Europe.
Tamiflu (oseltamivir phosphate), which is indicated for the prevention and treatment of influenza types A and B in patients over 1 year old, is currently available as a 75-mg capsule for adults and as a liquid suspension for children. With a longer shelf life than the liquid suspension formulation, pediatric capsules would provide a better option for government pandemic stockpiling, according to Roche.
The application was based on information already available for the 75-mg capsule. The method of manufacturing will remain the same. Roche said it is optimistic that the FDA will complete its review of the sNDA by mid-2007.
Roche has fulfilled pandemic stockpile orders for Tamiflu in more than 75 countries. The company has also donated more than 5 million courses of Tamiflu to the World Health Organization.