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03-10-2007, 01:37 PM #1
Roche Applies To FDA To Create Child-Size Tamiflu
Roche applies to create child-sized Tamiflu
The drugmaker asks the FDA for approval to make two smaller-sized doses of the capsules.
March 9 2007: 3:13 PM EST
WASHINGTON (Reuters) -- Tamiflu-maker Roche said it applied to make a new child-sized dose of its influenza drug Friday.
The company, which makes Tamiflu under agreement from California-based Gilead Sciences, said it asked the U.S. Food and Drug Administration for approval to make two smaller-sized doses of the capsules.
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Tamiflu, known generically as oseltamivir, can both treat and prevent influenza if given soon enough. It works against both seasonal influenza and H5N1 avian influenza, which some experts fear could cause a pandemic if it mutates in just the right way.
It is currently made in 75 mg doses, but Roche said 30 mg and 45 mg sizes would be easier for children to use. It also makes a liquid suspension, but that formulation expires after two years.
"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 said in a statement.
Governments and companies around the world are stockpiling Tamiflu and a rival drug, GlaxoSmithKline's (down $0.11 to $55.52, Charts) Relenza, in case a pandemic does break out.
Shares of Roche (down $0.15 to $88.15, Charts) were little changed in late-session trading on Nasdaq. Shares of competitors Johnson & Johnson (up $0.42 to $62.14, Charts) and Pfizer (up $0.03 to $25.44, Charts) edged slightly higher.
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