FDA approves Botox to smooth wrinkles
WASHINGTON (CNN) -- The Food and Drug Administration announced Monday it has approved a product called Botox Cosmetic to treat moderate to severe frown lines between the eyebrows.
Botox is made from the toxin that causes the food poisoning known as botulism. It smoothes facial lines by paralyzing or weakening the muscles that can cause frowning.
The FDA initially approved Botox in December 1989 to treat eye muscle disorders. The product again was approved in December 2000 to treat cervical dystonia, a neurological disorder that causes severe neck and shoulder contractions. Allergan Inc., the product's manufacturer, also will market Botox Cosmetic.
"Our successful clinical work shows that Botox Cosmetic is safe and effective for this aesthetic use," said Lester J. Kaplan, Allergan's president of research and development and Global Botox.
"Along with the previous approvals in the U.S. for Botox, in the treatment of certain neurological disorders, this new indication firmly establishes the versatility of the product."
Studies show that after 30 days' use, the severity of the frown lines in patients injected with Botox Cosmetic was reduced for up to 120 days.
The FDA is recommending that Botox Cosmetic should be injected only once every three months, using the lowest effective dosage. It is available by prescription only.
Costs vary around the country but average about $400 a treatment, according to The Associated Press.
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