To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Repliderm Wound Dressing Receives FDA Marketing Clearance URL: http://www.pslgroup.com/dg/123DE.htm Doctor's Guide January 15, 1997
MINNEAPOLIS, Jan. 15, 1997 -- ORPHAN MEDICAL, INC. (Nasdaq: ORPH) today announced the 510(k) marketing clearance of Repliderm(TM) Wound Dressing by the Food and Drug Administration (FDA). While an important development milestone, this 510(k) does not fully support indications Orphan Medical considers important to successfully market Repliderm. Therefore, Orphan Medical will not market Repliderm until clinical trials to evaluate these indications are completed. This 510(k) addresses the use of Repliderm as a collagen-based dressing for the management of pressure ulcers (stages I - IV), stasis ulcers, 1st and 2nd degree burns, diabetic ulcers, foot ulcers, post-surgical incisions, cuts, abrasions, partial thickness wounds, skin conditions associated with peristomal care, and wound exudate absorption. Orphan Medical's planned trials will evaluate whether Repliderm accelerates healing of decubitus ulcers, also known as bed sores or pressure ulcers. The U.S. market for wound healing agents is large. Decubitus ulcers are the most prevalent type of ulcer in the U.S. with an estimated one million occurring per year. Venous stasis ulcers, usually caused by impaired oxygenation of the lower limb tissues, affect around 250,000 patients annually. Repliderm is the fourth Orphan Medical product to receive FDA clearance. Two of these products, Cystadane(TM) (betaine anhydrous for oral solution) and Elliotts B(TM) Solution (buffered intrathecal electrolyte/dextrose injection) were launched in 1996. The third, Antizol-Vet(TM) (fomepizole) for injection will be launched in early 1997. Repliderm's active ingredient is Catrix(R), a product of Lescarden Inc., New York, N.Y. and is licensed to Orphan Medical. Orphan Medical, Inc. is dedicated to patients with inadequately treated or uncommon diseases. Orphan Medical acquires, develops and markets products of high medical value to well-defined patient populations treated by health care specialists. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.