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.

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.