Sinclair Pharmaceuticals receives FDA approval for Gelclair in U.S.

Jan. 21, 2002
Gelclair, a product that offers a novel approach to managing painful oral conditions by creating a film barrier within the mouth, has gained 510K (Medical Device) approval from the FDA.

Sinclair Pharmaceuticals Limited announces that Gelclair, their novel product for the management of oral mucositis, has gained 510K (Medical Device) approval from the US Food & Drug Administration.
Mucositis is a painful ulcerative and inflammatory condition affecting the mouth. It is seen alongside many chemotherapy regimens and radiotherapy to the head and neck. The pain of mucositis often prevents the patient from eating or drinking and so can result in the need to reduce a patient's treatment.
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