us food and drug administration

(Weber Shandwick Worldwide) The Myelodysplastic Syndromes Foundation supports the decision by the US Food and Drug Administration to extend the label for vidaza to include data from the AZA-001 clinical trial.

Results from the trial found that azacitidine is the only agent which has been shown to extend survival in MDS patients.

(Weber Shandwick Worldwide) The Aplastic Anemia & MDS International Foundation is pleased to inform patients that the US Food and Drug Administration has expanded the label for Vidaza (azacitidine) to include data from the AZA-001 trial, which found that Vidaza is the only agent that extends survival in MDS (myelodysplastic syndromes) patients.

Vidaza was also shown to delay progression to acute myelogenous leukemia in patients with MDS. Roughly 30 percent of patients diagnosed with MDS will progress to AML.

(University of Rochester Medical Center) The US Food and Drug Administration today approved tetrabenazine, the first drug approved for use in the United States to treat Huntington's disease, a fatal, inherited neurodegenerative disorder for which there is no cure.

(University of Rochester Medical Center) The University of Rochester Medical Center will collaborate with the US Food and Drug Administration to develop a national repository of data that will aid academic and industry researchers studying the electrical activity of the heart.

In addition to helping researchers understand many cardiac problems, the data may aid the development of new tools to detect drugs that can have dangerous effects on the heart.

(Cohn & Wolfe) GlaxoSmithKline announced today that the US Food and Drug Administration has approved KINRIX, the first combination vaccine to offer protection against diphtheria, tetanus, pertussis and polio diseases in one shot.

(University of Georgia) University of Georgia researchers have developed an effective technology for reducing contamination of dangerous bacteria on food.

The new antimicrobial wash rapidly kills Salmonella and E. coli O157:H7 on foods ranging from fragile lettuce to tomatoes, fruits, poultry products and meats.

It is made from inexpensive and readily available ingredients that are recognized as safe by the US Food and Drug Administration.

A while back, we posted frequently about the sudden toxicity of what used to be an apparently well understood drug. A summary of the story to date is below (in smaller type.):

(Scripps Research Institute) New findings from scientists at The Scripps Research Institute provide evidence that the drug gabapentin affects certain components of the alcohol addiction cycle in the brain, supporting the idea that the medication, which is approved by the US Food and Drug Administration for treating seizures and pain, also holds potential for the treatment of alcohol dependence.

(Cohn & Wolfe) Data presented today on Vanda Pharmaceuticals Inc.'s investigational drug candidate, iloperidone, included its 4-week, short-term Phase III trial, as well as a pooled analysis of three long-term, 52-week trials, studying the efficacy and safety of iloperidone.

Iloperidone is a 5HT2/D2 antagonist ("atypical") antipsychotic currently under review by the US Food and Drug Administration for the treatment of schizophrenia.

It is time to update the story of the contaminated heparin. A summary of the story to date is below (in smaller type.):