Roche files NDA for pediatric Tamiflu capsules

Mar 12 2007

Roche has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) to market Tamiflu (oseltamivir phosphate) capsules in pediatric doses of 30 mg and 45 mg.

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 75 mg capsule for adults as well as liquid suspension formulation for children. With a longer shelf life than the liquid suspension formulation (five years vs. 24 months), Tamiflu pediatric capsules provide a better option for government pandemic stockpiling and can be administered to children for seasonal influenza.

The application was filed based on information already available for the 75 mg 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, oseltamivir phosphate, filled into the capsule. Roche is optimistic that the FDA will complete its review of the sNDA by mid-2007.