Weekly Roundup – 5-11-07

J0289906 Well, it was quite a week, some of which I’ve already talked about – Kennedy-Enzi Senate passage; the Dendreon approvable letter for Provenge, a big Oxycontin settlement, and more and more melamine.  On my side of the fence, I’ve been traveling – New York, Denver and St. Louis.  I, for one, am happy to see the week end. 

But first, here is what else happened:

  • FDA Approves Neupro Patch for Treatment of Early Parkinson’s Disease – This week the agency announced the approval of Neupro (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson’s disease.  Rotigotine is a drug not previously approved in the United States but was approved in Europe in 2006 and is available in 14 countries.  Neupro is the first transdermal patch approved for the treatment of symptoms of Parkinson’s disease. Neupro Patch is manufactured by Schwarz Bioscience – a German company – of Research Triangle Park, N.C. 
  • FDA Issues Health Risk Alert for ‘True Man’ and ‘Energy Max’ ProductsYesterday, the FDA issued an advisory warning consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States. The products have been marketed as sexual enhancement products and as treatments for erectile dysfunction (ED).  The FDA regards them as illegal drug products because they contain substances with similar structures to active ingredients in approved prescription drugs.
  • Steven Galson Testifies – On May 9, Steven Galson, M.D., M.P.H., Director, Center for Drug Evaluation and Research before the Subcommittee on Health Committee on Energy and Commerce United States House of Representatives on drug safety.
  • New FDA Food Safety Expert Testifies – David Acheson, M.D., F.R.C.P., Assistant commissioner for Food Protection  before the Committee on Agriculture, U.S. House of Representations on melamine.  Look for more on this…

That’s it for now, have a good weekend folks.  Happy Mother’s Day to those of you who are moms.

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