In Brief: Theravance Inc.
Thursday, November 20 2008 | Comments
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Theravance Inc. received a favorable recommendation from the Food and Drug Administration's Anti-Infective Drugs Advisory Committee for telavancin in the treatment of complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. The committee voted 21-5 that the data presented demonstrated the safety and effectiveness of telavancin in this indication. It also voted 18-5 (with three abstentions) that there are special clinical situations in which the benefits of telavancin use in pregnant women with cSSSIs would outweigh the risks, and it voted 25-1 that a risk management strategy is needed to prevent unintended use of the drug in pregnant women or women of child-bearing potential. Print |
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