FDA Information - November 20, 2008

FDA Endorses Drug For Underdeveloped Children

September 1, 2005 - Topics fda, child, hospital, blood and food
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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FDA Approves Additional Flu Vaccine

September 1, 2005 - Topics fda, vaccine, flu, food and influenza
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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Top FDA Official Resigns Over Morning After Pill

September 1, 2005 - Topics fda, prescription, plan b, safety and food
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 Flu Vaccine Plant Gets FDA Approval

August 31, 2005 - Topics fda, plant, vaccine, flu and influenza
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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FDA Endorses New Japanese Diabetes Tablet

August 30, 2005 - Topics fda, diabetes, insulin, north america and food
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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