Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Dental and Oral Health | Immunology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Block Drug Company
Approval Status: Approved December 1997
Treatment Area: canker sores
A new prescription medication is now available to dentists and
physicians to provide help to millions of canker sore sufferers in
the U.S. Aphthasol (amlexanox oral paste, 5%), the first and only
prescription medication indicated specifically for the treatment of
canker sores, has been approved in patients with normal immune
systems. Aphthasol is available in 5 gram tubes.
Aphthasol was proven safe and effective when used as directed in
four clinical trials with more than 1,300 patients. The most common
adverse effects, as reported by 1-2% of patients, were transient
pain, burning, and/or stinging sensations at the site of
application. Clinical data confirms that best results from
Aphthasol occur with earliest possible use.