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EpiCeram FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved April 11, 2006)
Brand name: EpiCeram
Generic name: skin barrier
Dosage form: Emulsion
Company: Ceragenix Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis

EpiCeram Controlled Release Skin Barrier Emulsion is a steroid free, fragrance free ceramide dominant emulsion used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis.

Development timeline for EpiCeram

Sep 26, 2005Ceragenix Submits 510(k) Application to FDA for Epiceram, a Skin Barrier Cream for Treatment of Eczema and Other Skin Disorders

Further information

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