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FDA panel endorses antibacterial dalbavancin


 

AT AN FDA ADVISORY COMMITTEE MEETING

Dr. Magill also recommended that a postmarket study address pediatric patient populations.

"There are several unanswered questions about other patient populations, like pediatrics, and potential for other indications. I think what happens next is very important, whether it’s a postmarketing surveillance of some kind, required phase IV studies, or the sponsor seeking new indications with new data and a new trial," Dr. Magill said. "I’d be looking forward to see how that evolves."

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