Oral Mucositis

Access Pharmaceuticals receives MuGard marketing clearance from U.S. FDA

Published in FDA Law Weekly, January 18th, 2007

Access Pharmaceuticals, Inc., (ACCP.OB) announced that it had received 510(k) clearance from the Food and Drug Administration to market MuGard in the United States.

MuGard is Access' proprietary oral rinse product for the management of oral mucositis, the debilitating side-effect which afflicts more than 40% of cancer patients undergoing radiation and chemotherapy.

There is currently no well-accepted treatment for mucositis, and the company believes that MuGard should be a valuable supportive care option for cancer patients. The estimated size of the market for this indication in the U.S. exceeds $1 billion. The company is actively seeking marketing...

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Source: FDA Law Weekly (2007-01-18)

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