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US FDA refuses to accept Theravance's re-submission of Vibativ for hospital-acquired pneumonia

This article was originally published in Scrip

Executive Summary

The US FDA has dealt a major blow to Theravance's quest to gain a supplemental hospital-acquired pneumonia (HAP) indication for its injectable broad-spectrum antibiotic Vibativ (telavancin) by refusing to accept two Phase III studies that are supporting the sNDA as separate entities, since their primary endpoint data were pooled together.

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