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Roche Files sNDA for Tamiflu Pediatric Capsules

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Roche has filed a sNDA with the FDA to market Tamiflu capsules in pediatric doses of 30 mg and 45 mg. Tamiflu, which is indicated for the prevention and treatment of flu types A and B in patients one year and older, is currently available in a 75 mg capsule for adults and a liquid suspension formulation for children. Tamiflu pediatric capsules have a longer shelf life than the liquid suspension formulation (five years vs. 24 months) and 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, with exception of the size of the capsule and the amount of the active ingredient, oseltamivir phosphate. Roche anticipates that the FDA will complete its review of the sNDA by mid-2007.

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