Description of Medical Areas

About the FDA Approved Listings

Drugs Approved by the FDA

Drug Name: Aphthasol

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Block Drug Company
Approval Status: Approved December 1997
Treatment for: canker sores

General Information

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.

Clinical Results

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.


Back to Drug Listing



Drug listing last updated on June 20, 2008

CenterWatch Newly Approved Drug Therapies Listing
Copyright © 1995 - 2001, CenterWatch, Inc.

Copyright © 1995 - 2008, CenterWatch
All Rights Reserved

This site was developed in association with Illumina Interactive, Boston, MA