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...

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