Archive for February, 2010

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  FDA Approves New Indication for Crestor

  0February 9, 2010
  On Feb. 8 the U.S. Food and Drug Administration approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are...
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  Sagent Pharmaceuticals announces FDA approval of LABETALOL Hydrochloride Injection, USP

  0February 8, 2010
  Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has received FDA approval of labetalol hydrochloride...
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  FDA Issues Guidance to Help Streamline Medical Device Clinical Trials

  0February 5, 2010
  The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical...
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  FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science

  0February 2, 2010
  The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the...
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  FDA Approves Xiaflex for Debilitating Hand Condition

  0February 2, 2010
  The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive...
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  FDA Announces Safety Risk Associated with HIV Drug

  0February 1, 2010
  The U.S. Food and Drug Administration announced on January 29 that non-cirrhotic portal hypertension, a rare, but serious, liver disorder,...