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The FDA approved the sale of a lower dose Tamiflu capsule in the United States today, making it easier to administer pediatric doses.
FDA approves Roche's low dose Tamiflu for children
Mon Jul 2, 2007 11:07PM BST
NEW YORK (Reuters) - 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.
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