New FDA approvals

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Subject: New FDA approvals

Factive (gemifloxacin) Tablets

Manufacturer: LG Life Sciences, Ltd

Drug Approval Classification: Original New Drug Application (Approval

Date: 04/04/03)

Indication:Factive (gemifloxacin) is indicated for the treatment of:

Acute bacterial exacerbation of chronic bronchitis (ABECB) caused by

Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus

parainfluenzae, or Moraxella catarrhalis.

Community-acquired pneumonia (CAP) (of mild to moderate severity) caused

by S pneumoniae, H influenzae, M catarrhalis, Mycoplasma pneumoniae,

Chlamydia pneumoniae, or Klebsiella pneumoniae.

Dosing: Gemifloxacin dosing is described in Table 1. Gemifloxacin can be

taken with or without food.

Dose modifications are recommended for patients with creatinine

clearance </= 40 mL/min.

Clinical Summary: Gemifloxacin is in the fluoroquinolone class of

antibiotics.

Gemifloxacin may prolong the QT interval in some patients. Gemifloxacin

is not recommended for patients with a history of prolongation of the QT

interval, electrolyte disorders, and patients receiving class IA or

class III antiarrhythmic agents.

Gemifloxacin has not been studied in children, adolescents, pregnant

women, or lactating women.

ABECB: Gemifloxacin 320 mg once daily orally for 5 days was studied in 3

double-blind, randomized, actively controlled clinical trials. The

primary efficacy parameter in these studies was the clinical response at

follow-up (day 13 to 24). The difference between comparators

(clarithromycin, amoxicillin/clavulanate, and levofloxacin) in favor of

gemifloxacin ranged from 0.4% to 3.1%.

CAP: For the treatment of CAP, gemifloxacin 320 mg once daily orally for

7 days was studied in 3 double-blind, randomized, actively controlled

clinical studies, 1 open, actively-controlled study, and 2 uncontrolled

studies. Treatment difference between gemifloxacin and comparators in

favor of gemifloxacin was 1.1%.

Adverse Effects: The incidence of drug-related rash was 2.8%. The

development of rash occurred 8 to 10 days after initiation of therapy.

Gemifloxacin most commonly produced a mild to moderate maculopapular

rash.

Other adverse events reported in clinical development include nausea

(0.3%), diarrhea (0.3%), urticaria (0.3%), and vomiting (0.2%).

Pharmacokinetics: Gemifloxacin follows linear pharmacokinetics. The

pharmacokinetics of repeated 320-mg doses yielded a maximum plasma

concentration of 1.61 mcg/ml and an area under the curve of 9.93

mcg*hr/ml.

Gemifloxacin is metabolized in the liver. Up to 65% is unchanged and

excreted.