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FDA requires additional phase 3 trial of Targanta antibiotic
Washington - The Food and Drug Administration (FDA) is requiring Targanta Therapeutics to conduct an additional phase 3 trial of its antibiotic oritavancin, according to fdanews.com.
Washington
- The Food and Drug Administration (FDA) is requiring Targanta Therapeutics to conduct an additional phase 3 trial of its antibiotic oritavancin, according to fdanews.com.
In order for oritavancin NDA to treat complicated skin and skin structure infections, the study must include subjects with methicillin-resistant Staphylococcus aureus, and several safety concerns must be addressed, including a high rate of participants dropping out due to lack of efficacy and serious adverse events, according to the release.
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