FDA approves Roche’s low dose Tamiflu for children

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Swiss drugmaker Roche Holding AG said on Monday that U.S. health regulators approved its Tamiflu influenza treatment at two lower doses for children in a form with a longer shelf life that could be an advantage for use in stockpiling against a flu pandemic.

The U.S. Food and Drug Administration approved Tamiflu capsules for sale at 30 milligram and 45 mg doses for the treatment and prevention of influenza types A and B in patients one year and older, Roche said.

The shelf life of the capsules is five years, the company said, considerably longer than that of the 24-month shelf life of the standard liquid suspension formulation.

Many countries are stockpiling the anti-viral drug with the hope that it will be able to lessen the effects of an influenza pandemic if and when one strikes.

The 30 mg and 45 mg capsules will be available nationwide and for government stockpiling in time for the 2007-2008 flu season, Roche said.

“Roche continues to take steps to facilitate the use of antivirals in pandemic preparedness and response,” Dominick Iacuzio, medical director at Roche, said in a statement.

“These lower dose capsules not only provide governments with a new option for pandemic stockpiling, but also give prescribing physicians an alternative for patients who prefer a capsule formulation,” he said.

Roche has received Tamiflu orders totaling 215 million treatment courses from more than 75 countries. It has also donated 5.1 million Tamiflu treatment courses to the World Health Organization to help contain any initial pandemic outbreak.

Roche said it has filled orders from the U.S. government and states for 43.7 million Tamiflu treatment courses so far.

Tamiflu will continue to be available in a 75 mg capsule for adults as well as liquid suspension formulation for children, the company said.

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