 FDA Information - November 20, 2008
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The Food and Drug Administration approves the first drug to treat children who suffer from a condition what stunts growth. Dr. Philippe Backeljauw of Cincinnati Children's Hospital says that the drug called Increlex will treat children whose growth failure is related to unusually low levels of a hormone called IGF-1 |
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A new flu shot, Fluarix, earns The Food and Drug Administration's approval in a push to have more available flu vaccines after last year's unexpected shortage. Fluarix is a flu shot made in Germany by a subsidiary of GlaxoSmithKline and is approved for use in adults 18 and older |
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In an unprecedented display of public animosity at the Food and Drug Administration, one of its top employees resigns Wednesday to protest the agency's refusal to allow over-the-counter sales of emergency contraception. Assistant Commissioner Susan Wood charges that FDA's leader overruled his own scientists' determination that the morning-after pill could safely be sold without a prescription, and stunned his employees last week by postponing indefinitely a decision on whether to let that happen, The Associated Press reports |
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Chiron Corp. says on Wednesday that it expects to provide a vaccine for the 2005-2006 flu season after a recent favorable inspection of the plant by U.S. regulators, reports Reuters The company had to postpone U.S. sales of its flu vaccine last year due to contamination problems at its plant in England, which led to the withdrawal of its manufacturing license for Fluvirin last October |
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Takeda Pharmaceutical Co. announces on Tuesday that it has obtained consent from the U.S. Food and Drug Administration for its new diabetes drug, reports The Associated Press. Actoplus Met is a single tablet that merges Takeda's two existing diabetes drugs, Actos and Metformin. Takeda Pharmaceuticals North America Inc. will sell the tablet in the United States starting in October |
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