FDA Approves New Impetigo Treatment
Ointment Called Altabax Treats Children and Adults With the Skin Infection
April 13, 2007 -- The FDA today approved a new prescription antibacterial
ointment called Altabax to treat impetigo.
Impetigo is a highly contagious skin infection caused by bacteria. It's most
common among children and is usually spread through physical contact with
someone who has impetigo, or from sharing clothes, bedding, towels, or other
Altabax is for patients who are at least 9 months old and have impetigo due
to the common bacteria Staphylococcus aureus or Streptococcus
pyogenes, states GlaxoSmithKline, which makes Altabax.
Altabax represents the first new class of prescription topical
antibacterials to be approved by the FDA in nearly 20 years, notes
Altabax is used twice daily for five days. Other prescription topical
antibiotics are used as much as three times daily for up to 12 days, says
The FDA approved Altabax based on effectiveness data from a study of 210
adults and children with impetigo.
A total of 139 patients received Altabax. The others patients got an
ointment containing no medicine (placebo).
After five days of treatment, success was more common in the Altabax group
than in the placebo group, according to GlaxoSmithKline.
The FDA says it also reviewed safety data on approximately 2,000
Altabax-treated adults and children who were at least 9 months old and another
1,000 patients who used other antibiotics or a placebo.
The most common Altabax-related adverse event was irritation at the
application site. That problem affected less than 2% of the patients, notes the