Regulatory Information
Sucralfate, the active ingredient in Chemokit™, has two unique characteristics: It balances the electrical resistance of the mucosal tissue acting as a preventive agent and directly binds to proteins of the ulcerated oral mucosa for 6-8 hours. This creates a long-lasting protective barrier that is not felt in the mouth and is not disrupted by eating or by talking. Sucralfate is not absorbed into the bloodstream and has practically no adverse reactions.*
Sucralfate paste/mixture is acknowledged by the FDA as a Wound Dressing. Chemokit is currently undergoing feasibility and clinical trials before submission to the FDA.
* Consumption should be restricted only when patients suffer renal failure, because of the possible danger of aluminum accumulation in the body.
The hyper-immune colostrums of Anadis, to be included in AM-Kit™ for treatment of Alimentary Mucositis, are considered as GRAS (Generally Recognized as Safe).
Therefore - The SMS device with those drugs in a freshly prepared Galenic formulation will be submitted as a device, in a short regulatory 510(k) path
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