Supplemental New Drug Application (sNDA) for Pediatric Doses of Tamiflu®, Submitted by Roche to USFDA
Tamiflu® is indicated for the prevention and treatment of influenza types A and B in patients one year and older and is currently available in a 75 mg capsule for adults and as liquid suspension formulation for children.
Roche –maker of Tamiflu® - has recently filed a supplemental new drug application (sNDA) to the USFDA to market Tamiflu® (oseltamivir phosphate) capsules in pediatric doses of 30 mg and 45 mg.
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.
Roche is expecting the FDA to finish reviewing the sNDA in mid-2007.
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