Back to FDA Approvals 2004
OraDisc A
Generic Name: amlexanox mucoadhesive patchDate of Approval: September 29 ,2004
Company: Access Pharmaceuticals, Inc.
Treatment for: Aphthous Ulcers
The U.S. Food and Drug Administration (FDA) has approved OraDisc A, an improved delivery system for amlexanox, which has previously been approved by the FDA for the treatment of canker sores.
The OraDisc technology is a proprietary mucoadhesive patch which gradually erodes and releases an active ingredient when applied to the inside of the mouth.
The approval of this new drug application provides for the use of the amlexanox mucoadhesive patch 2mg for the treatment of aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system.
In the clinical program undertaken by Access for OraDisc A, pediatric patients 12 years of age and older were included in the studies. This has enabled us to extend the potential use of amlexanox to include patients 12-17 years of age which is considered an important patient group for this indication.
For more information, please see Amlexanox Consumer Information
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Aphthous Stomatitis - Recurrent
