EpiCeram
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EpiCeram (EpiCeram Skin Barrier Emulsion) is a topical non-steroidal skin cream. Based on the research of Peter M. Elias,[1] it is made up of ceramides, free fatty acids, and cholesterol, and is designed to treat atopic dermatitis,[2] a type of eczema.[3][medical citation needed] Ceragenix obtained marketing clearance from the U.S. Food and Drug Administration in April 2006.[4] This prescription medical device[5][failed verification] works as a moisturizer and barrier cream. In the US, it requires prescription and was launched in October 2008 by Promius Pharma.[1] EpiCeram was acquired by PuraCap Pharmaceutical LLC in 2010.
EpiCeram obtained Health Canada medical device license in September 2009 and was launched by Pediapharm in November of the same year. It is sold under prescription.
References
[edit]- ^ a b "Home - Ceragenix". Archived from the original on 2010-04-13. Retrieved 2010-06-10.
- ^ Madaan, Arvind (October 2008). "Epiceram for the treatment of atopic dermatitis". Drugs of Today. 44 (10): 751–755. doi:10.1358/dot.2008.44.10.1276838. ISSN 1699-3993. PMID 19137128.
- ^ "EpiCeram US – Importance Of Healthy Lifestyle". EpiCeram US – Importance Of Healthy Lifestyle. 2020-08-17. Retrieved 2021-02-12.
- ^ "April 2006 510(k) Clearances". Food and Drug Administration. Archived from the original on 2012-10-14. Retrieved 2019-12-16.
- ^ "Establishment Registration & Device Listing". Accessdata.fda.gov. Retrieved 2021-02-12.
External links
[edit]- "Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis". U.S. National Institutes of Health. February 5, 2008. Entry at ClinicalTrials.gov
- "Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis". U.S. National Institutes of Health. February 5, 2008. Entry at ClinicalTrials.gov