MuGard
Generic name: oral mucoadhesive
Treatment for: Mucositis
Access Pharmaceuticals Announces the Filing of an FDA 510(K) Application for MuGard
DALLAS, September 20, 2006 -- Access Pharmaceuticals, Inc. announced today that it has submitted a Premarket Notification 510(k) Application to the United States Food and Drug Administration announcing the Company's intent to market MuGard.
MuGard is Access' proprietary oral rinse product for the prevention and treatment of oral mucositis, the debilitating side-effect which afflicts more than 20% of cancer patients undergoing radiation and chemotherapy. In previously reported clinical studies MuGard prevented significant mucositis in over 40% of patients in a population where the incidence of mucositis normally exceeds 90%. There is currently no well-accepted treatment for mucositis, and the Company believes that these results demonstrate that MuGard should be a valuable supportive care option for cancer patients.
Posted: September 2006
MuGard (oral mucoadhesive) FDA Approval History
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