QTc and Quinolones: recent regulatory actions

5/23/01


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Table of Contents

QTc and Quinolones: recent regulatory actions

Overview: Quinolone Antibiotics

Background

Background

Moxifloxacin (Avelox)

Anti-infectives Advisory Committee (10/99)

Pre-Clinical Animal Data: Moxifloxacin

All Patients with ECGs

Mean changes of QTcB (QT) in mS for patients with valid paired ECGs

PPT Slide

Mean prolongation of QTc

Summary

Gatifloxacin (Tequin)

Gatifloxacin

Selected Characteristics

Quinolone Characteristics

Considerations at Approval

Approach to Regulatory Action

Gatifloxacin (Tequin ) Label

Approach to Regulatory Action

Approach to Regulatory Action

ODE IV Continuing Response

Patient Information About: TEQUIN 200 mg and 400 mg Tablets

Patient Information About: TEQUIN 200 mg and 400 mg Tablets

Author: CDER USER