Wednesday, January 26, 2011

Glaxo Denied US Approval for Expanded Use of Avodart for Prostate Cancer

GlaxoSmithKline Plc said it failed
to win approval from U.S. regulators for expanded use of its
enlarged-prostate therapy Avodart to treat the estimated 1
million American men at risk for prostate cancer.
Glaxo received a so-called complete response letter from
the U.S. Food and Drug Administration rejecting the application
to expand Avodart’s use, the London-based company said today in
a statement. An FDA advisory panel voted 14-2

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