The Fluoroquinolone Toxicity Research Foundation

 
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Avelox Label Changes Research   See downloads for: Adobe Files



DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
Rockville, MD 20857
NDA 21-085/S-024
NDA 21-277/S-019
Bayer Pharmaceuticals Corporation
Attention: Robin M. Christoforides
Deputy Director, Regulatory Affairs
400 Morgan Lane
West Haven, CT 06516
Dear Ms. Christoforides:
Please refer to your supplemental new drug applications dated April 7, 2004, received April 9, 2004,
submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for AVELOX ®
(moxifloxacin hydrochloride) Tablets and AVELOX® (moxifloxacin hydrochloride in NaCl injection)
I.V.
These “Changes Being Effected” supplemental new drug applications provide for the addition of
quinolone class labeling as requested in our supplement request letter dated November 26, 2003 and in
our facsimile dated March 10, 2004. The following revisions have been made to the package insert
under the WARNINGS section (additions are double underlined and deletions are strikethrough):
Peripheral neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting
small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have
been reported in patients receiving quinolones.
Tendon Effects: Ruptures of the shoulder, hand, Achilles and other tendon ruptures tendon or
other tendons that required surgical repair or resulted in prolonged disability have been reported in
patients receiving quinolones, including with quinolones, including moxifloxacin. Post-marketing
surveillance reports indicate that the this risk may be increased in patients receiving concomitant
corticosteroids, especially in the elderly. Moxifloxacin should be discontinued if the patient
experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from
exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can
occur during or after therapy with quinolones, including moxifloxacin.
We completed our review of these supplemental new drug applications. They are approved effective
on the date of this letter, for use as recommended in the final printed labeling (FPL) submitted on
April 7, 2004.
NDA 21-085/S-024
NDA 21-277/S-019
Page 2
If you issue a letter communicating important information about these drug products (i.e., a “Dear
Health Care Professional” letter), we request that you submit a copy of the letter to these NDAs and a
copy to the following address:
MEDWATCH, HFD-410
FDA
5600 Fishers Lane
Rockville, MD 20857
We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
314.80 and 314.81).
If you have any questions, call Robin Anderson, R.N., M.B.A., Labeling Reviewer at (301) 827-2127.
Sincerely,
{See appended electronic signature page}
Renata Albrecht, M.D.
Director
Division of Special Pathogen and Immunologic
Drug Products
Office of Drug Evaluation IV
Center for Drug Evaluation and Research