Canker Sores

FDA approves OraDisc A delivery system NDA for canker sores

Published in Biotech Business Week, October 25th, 2004

Access Pharmaceuticals, Inc., (AKC) announced the receipt of approval of its new drug application for OraDisc A from the U.S. Food and Drug Administration (FDA).

OraDisc A is 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...

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Source: Biotech Business Week (2004-10-25)

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