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GlaxoSmithKline PLC won approval to market its new anti-bacterial treatment Altabax to treat the skin infection impetigo, caused by strains of Staphylococcus aureus or Streptococcus pyogenes--the two most common types of bacteria in this kind of infection.

FDA ROUNDUP: GlaxoSmithKline PLC won approval to market its new anti-bacterial treatment Altabax to treat the skin infection impetigo, caused by strains of Staphylococcus aureus or Streptococcus pyogenes--the two most common types of bacteria in this kind of infection. Widespread use of antibiotics has led to bacteria becoming resistant to some drugs, creating a need for new treatments. Glaxo says Altabax is the first of a new class of prescription antibacterial drugs in nearly two decades. The company said that Altabax, also known as retapamulin belongs to a new class of antibiotics, called pleuromutilins, that inhibit bacteria from making proteins. In other action, the FDA confirmed on its Web site that Boston Scientific Corp. (Natick MA) recalled some of its cardiac defibrillators earlier this month. As of March 30, Boston Scientific said it confirmed 19 field events with some of the devices in question, mostly related to premature battery depletion. There were no serious injuries or deaths reported. And an FDA panel said Merck & Co.'s (Whitehouse Station NJ) experimental arthritis drug Arcoxia shouldn't be allowed on the U.S. market, citing some of the same risks that led to the withdrawal of the similar treatment Vioxx. The committee voted 20-1 Friday to recommend that the FDA reject Arcoxia because its benefits in reducing pain and minimizing stomach irritation don't outweigh potential danger to the heart. The FDA usually follows the recommendations of its advisers, although it isn't required to do so. The agency must make a final decision by April 27.
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Title Annotation:FDA ROUNDUP
Publication:MondayMorning
Article Type:Brief article
Date:Apr 16, 2007
Words:252
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