www.fdanews.com/articles/81168-ceragenix-submits-510-k-application-to-fda-for-epiceram-a-skin-barrier-cream
CERAGENIX SUBMITS 510(K) APPLICATION TO FDA FOR EPICERAM, A SKIN BARRIER CREAM
September 26, 2005
Ceragenix Pharmaceuticals, a development stage biopharmaceutical company, recently announced that Ceragenix Corporation, its wholly owned subsidiary, has submitted a 510(k) application to the FDA. The application seeks marketing clearance for Epiceram, a topical cream intended for use in alleviating the pain, itching and burning of atopic dermatitis (eczema), irritant contact dermatitis, radiation dermatitis and xerotic skin conditions. If cleared by the FDA, Epiceram will be the Company's first commercial product.