Theravance Inc. (THRX) said that telavancin received a favorable recommendation from the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration for the proposed indication to treat complicated skin and skin structure infections caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus.
The Committee said that the data presented demonstrate the safety and effectiveness of telavancin for treatment of cSSSIs.
The Committee also said that there are specific clinical situations in which the benefits of telavancin use in pregnant women with cSSSI would outweigh the risks, and that a risk management strategy is needed to prevent unintended use of telavancin in pregnant women or women of child-bearing potential.
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