GlaxoSmithKline Will Submit for FDA Approval Expanded Use for AvodartBritish GlaxoSmithKline Plc. announce their intention to submit for the second time for Food and Drug Administration approval extended use of Avodart (dutasteride) as a treatment to reduce the risk of prostate cancer among men at increased risk of developing the disease.
03-30-2010 |
18:26 hs.
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British GlaxoSmithKline Plc. announce their intention to submit for the second time for Food and Drug Administration approval extended use of Avodart (dutasteride). The drug had sales of 827 million dollars during 2009, the eight best selling drug for GSK, and is looking to be approved to reduce the risk of prostate cancer among men at risk of developing the tumor. GlaxoSmithKline withdrew FDA filed documentation last November 24th. under the sNDA application. Data arose over the clinical study that showed a 25 percent risk reduction of prostate cancer. Glaxo said that file withdrawal was to gather more consistent and accurate information. Publish comment:
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