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Adcom: Changes are needed in labeling of fluoroquinolone antibiotics

By Mari Serebrov
Regulatory Editor

Friday, November 6, 2015

Reflecting the concerns voiced by nearly three dozen patients in a public hearing, members of the FDA's Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted Thursday to recommend changes in how systemic fluoroquinolone drugs are labeled to treat a trio of non-life-threatening infections.

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